Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Recommendations (what to do, contacts with the manufacturer, how to notify Anvisa, etc.): Immediately return the affected products to the representative of the company holding the registration. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 05/02/2018 - Date of notification notice to Anvisa: 05/14/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Immediately discontinue use of the affected products (see affected affected fields and serial numbers affected by this alert and details in Attachment A of the Letter to Customer) Quarantine and return unused product codes and batches of listed items. used codes and batches of affected items must be returned as described in the Required Actions section of the Customer Letter.All unused product codes and batches of affected items must be returned to the company or distributors.If you wish to notify technical complaints and adverse events please use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http://portal.anvisa.gov.br/notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution option o / Entity, if you are a professional of an institution / entity. System of Technovigilance: Patient or citizen can notify through the System of Tecnovigilância / SISTEC access through the link http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp - Date of identification of the problem by the company: 05/23/2018 - Notification date for Anvisa: 05/24/2018 The company holding the record of the affected product is responsible for contacting its clients in a timely manner to ensure the effectiveness of the ongoing Field Action. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Users / patients and distributors should take the following actions: 1. Operators may continue to use the Prismaflex control units that have not displayed the "Out of Range Voltage" malfunction alarm. 2. According to the company, a technical representative will go to your institution to determine the corrective plan and schedule the firmware update. 3. If you purchased this product directly from Baxter, complete the attached customer response form and return it to Baxter via e-mail to faleconosco@baxter.com or fax to (XX) 11 5635-0106 or 0800 012 5522 , even if there is no remaining stock at your facility. Prompt return of the customer response form will confirm receipt of this notification and will prevent you from receiving this notice several times. 4. If you distribute this product to other institutions or departments within your institution, please send a copy of this document to them. 5. If you are a reseller, wholesaler, distributor or original equipment manufacturer (OEM) distributing any affected product to other institutions, please notify your customers about this Urgent Medical Device Correction in accordance with the usual procedures. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 03/03/2018 - Date of notification notice to Anvisa: 05/23/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The following steps should be taken: 1. Check immediately if you still have the catalog and batch (s) in your inventory. If you have units in stock, discontinue and segregate them. 2. Share this notification with any other users of this product at your institution to make sure everyone is aware. 3. Complete the form attached to the letter to the customers, stating whether or not you have any affected product, and send the e-mail BRCR@bd.com, so that the company becomes aware of the receipt of this notification. Proceed with the collection and replacement of the products, if you still have units of the lots informed. 4. Notify the company and ANVISA of any adverse events that occurred, related to the situation described in this notification. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 04/23/2018 - Date of notification notice to Anvisa: 05/16/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The following steps should be taken: 1) Check your entire stock for the product / lot code combinations affected by this recall. 2) If you have distributed any batch number / code, please contact your customer immediately and alert him / her to the recall by requesting that you return the affected product to Bard Brasil Indústria e Comércio de Produtos para Saúde Ltda. 3) Segregate any identified product from your stock. 4) Once the product affected by this collection is identified and withdrawn from its stock; fill out the form attached to the Letter to the Client. Report exactly the quantities and lot numbers of each product of this recall that you have in stock. 5) If you have used any listed product, complete the recall verification form stating that no product will return. If you have any questions, please contact the company: e-mail Sao-tecnovigilancia@crbard.com. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 04/23/2018 - Date of notification notice to Anvisa: 05/21/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Patients receiving therapy with BBIA are in critical condition. Failure to start or stop suddenly may result in unsafe hemodynamic instability. Until the top protective cover is installed by the company, follow the instructions below when using the Cardiosave intra-aortic balloon pump: 1) According to the Care section of the BBIA Cardiosave Operating Instructions, "Never place fluids on the top of this unit. Make sure that the vessel and the saline tubing are not hung directly on the BBIA. In the event of an accidental spill, immediately clean and inspect the unit to make sure there are no risks. "2) In an unusual event in which a sudden interruption of therapy occurs, transfer the patient to an alternative BBIA. The Instructions for Use of the Intra-Aortic Balloon Catheter (BIA), reiterates that the catheter should not remain inactive for more than 30 minutes due to the potential formation of thrombi. If an alternative BBIA is unavailable, inflate the BIA manually with air or helium and aspirate immediately, repeat every 5 minutes until BBIA is available, or alternatively the intra-aortic balloon catheter should be removed from the patient. Check the instructions for use of the intra-aortic balloon catheter, and inflate and manually disinfect the catheter. The patient should be treated according to the treatment protocols of his unit and the clinical criteria of the caregivers to ensure hemodynamic stability. 3) If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: // portal .anvisa.gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 04/05/2018 - Date of notification notice to Anvisa: 05/15/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company makes the following recommendations for managing the power supply of the HVAD Systems in the Customer Charter: • Reinforce the importance of always ensuring that TWO power sources (AC or DC adapter plus one battery OR two batteries) are connected to the entire (except when changing the power source). Reinforce best practice guidelines for managing power supplies when you sleep and wake up: - Go to sleep, connect a fully charged battery, and then plug in the AC adapter. - When getting up in the morning, be sure to connect two fully charged batteries. Instruct patients to report persistent and unexpected audible sounds to the VAD team for additional instructions. Refer to Appendix A of the Customer Charter: HVAD System with Controller 1.0 - Identifying Behaviors of Unexpected Power Source Change. Refer to Appendix B: HVAD System with Controller 2.0 - Identifying Behaviors of Unexpected Power Source Change. Report any unexpected events to your local Medtronic representative and file a complaint, including records of the normal processes. If unexpected behavior persists and is responsible for possible confusion or anxiety of the patient, consider instead replacing the suspected source of energy and returning it to Medtronic for analysis during the complaint handling process. If unexpected behavior continues after replacement of the suspected energy source, consider replacing the Controller - if the condition of the patient allows according to the clinical judgment. Refer to the HVAD System Instructions for Use for detailed guidelines on controller replacement performance. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 01/05/2018 - Date of notification notice to Anvisa: 05/08/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company that holds the registry recommends the following actions: 1. Inspect the inventory immediately to identify the existence of products subject to this recall; 2. After identification, segregate the units and report the problem to the relevant staff of the surgical or material management center; 3. Fill in the Commercial Response Form (FRC) (Annex 2), confirming receipt of the notice within three (3) business days. 4. Keep the communication in a visible place until all batches of products subject to recall have been returned to the company that holds the record. 5. Immediately return all batches of unused and recalled Scissors that are in your inventory until August 31, 2018. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA ) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http://portal.anvisa.gov.br/notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 09/05/2018 - Date of notification notice to Anvisa: 05/28/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The manufacturer considers that there is no risk to patients who have been previously examined. The company said that the technical assistance organization will contact customers to arrange for corrective action, but it is possible to contact the technical assistance organization to schedule a more urgent appointment. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 04/26/2018 - Date of notification notice to Anvisa: 05/25/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company informs customers that in most cases, labs do not need to review past results or retest patients because cross-contamination and the generation of false positive results are usually rare and require the presence of a high titre sample in the battery tested. It states that if the samples were tested for the diagnosis of acute and self-limited conditions, there would be no benefit to the patient from a retrospective review of previous results or a retest. It reports that a review of previous results is relevant only in cases where the MagNA Pure 24 Pathogen (200 and / or 1000) protocols were used to extract nucleic acids for an assay of a chronic infectious disease (eg hepatitis C) and one change in outcome could affect treatment outcome. Reports that suspected false positive results that could potentially affect patient behavior should be retested according to local procedures using the MagNA Pure Instrument with the recently released Pathogen200 hp or Fast Pathogen 200 protocols or the External Lysis Pathogen 200 and 500 protocols or an alternative method. It states that since cross-contamination and the generation of false positive results are considered rare and require the presence of a high titre sample (unlikely frequency), until the updated Pathogen200 and Pathogen1000 protocols are available, users can: 1. Use the newly released Pathogen200 hp or Fast Pathogen 200 protocols or the External Lysis Pathogen 200 and 500 protocols, if available in your country; 2. Use an alternate method for testing purposes. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 04/13/2018 - Date of notification notice to Anvisa: 05/11/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Make sure that the organization that serves your CT scanning system is aware of this potential risk and wear protective gloves when using the wheel rims on the cover until GE Healthcare can correct it. The company states that there is no risk to its patients or to its CT Operators / technicians, only to field engineers capable of performing internal equipment maintenance. It states that customers can continue to use their system while waiting for this fix. All affected systems will be inspected as part of this Field Action. The inspection will include verification of damage to the cable and proper routing of cables. Those systems that have damage to the cable will receive a replacement. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 04/26/2018 - Date of notification notice to Anvisa: 05/11/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Segregate the product under risk from your inventory, identifying it to avoid inadvertent use. Contact the dealer from whom you purchased the product to exchange the product. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 19/04/2018 - Date of notification notice to Anvisa: 05/10/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Manufacturer's Recommendations: 1. Locate and segregate all batches of affected products within your institution. The product code and batch number can be found on the products or in the shipping boxes. 2. If you purchased this product directly from the company holding the registration, fill out the customer response form and send to the company via e-mail to faleconosco@baxter.com or via fax to (XX) 11 5635-0106 or to 0800 012 5522, informing the quantity present in your stock, even if there is no remaining stock in your facility. The prompt return of the customer response form will confirm receipt of the notification and will prevent you from receiving the notice several times. 3. Once this is done, the company will contact you to arrange for return and credit. 4. If you distribute this product to other institutions or departments within your institution, please send a copy of that document to them. 5. If you are a reseller, wholesaler, distributor or original equipment manufacturer (OEM) distributing any affected product to other institutions, please conduct the collection at the customer level that you distributed the affected products. Then inform the company according to the procedure described in step 2. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http://portal.anvisa.gov.br/notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 03/04/2018 - Date of notification notice to Anvisa: 05/10/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Recommendations (what to do, contacts with the manufacturer, how to notify Anvisa, etc.): Through the Urgent Security Notice Letter, users will be informed that the "MR Surgical Suite Table" table may continue to be used, , however, refer to the Operator's Manual for detailed descriptions of the various safety interlocks and operating mechanisms. They will also be advised to monitor any problems in releasing the transfer board from the Surgical MR GE table, and should contact the field engineer of the company holding the registration if they encounter any problems. They will also be instructed to test all patient transfer features as described in the Urgent Safety Notice Letter as part of a quality check before each procedure. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 10/20/2017 - Date of notification notice to Anvisa: 05/11/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company informs customers that they are aware of changes in the detection limits of the instructions for use of test strip products for each individual test parameter. Therefore, the following solution needs to be performed until further notice: If Urisys 1100® is reporting negative results for Protein, Nitrite, Ketones, Leukocytes or Blood (intact red cells), check the result by visual reading using the color scale supplied in the vial of test strips. In the case of discrepant values, the visually determined value should be reported. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 04/17/2018 - Date of notification notice for Anvisa: 08/05/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company informs the customers of users of the lots mentioned that interrupt their use. The balance in stock, if any, must be returned to the care of the holder of the registration or properly discarded, with proof of disposal. The company will reset the number of affected kits. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 03/04/2018 - Date of notification notice to Anvisa: 05/08/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Recommendations (what to do, contacts with the manufacturer, how to notify Anvisa, etc.): The company recommends users that if any of the following occur, stop using the system and call the Philips representative: • lift movement and slope do not work. • if you hear a different click from normal sounds during hoist or tilt movement. • if you notice a blockage in the lifting or tilting movement during system movements. • the system is crashing accidentally, or has been in the past two months. • a CPR holder has been used that has obstructed the system; or • has noticed any (unusual) behavior of the system, at odds with its normal use. Also, it is recommended that you avoid collisions with the table or the support platform of the system, ensuring that there is no obstacle around the system. It informs the need for the customer to ensure that all employees who have access to affected systems become aware of the contents of this Security Notice. Put a copy of the Safety Notice together with the system documentation until it has been repaired by Philips. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 01/05/2018 - Date of notification notice to Anvisa: 05/08/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Recommendations (what to do, contacts with the manufacturer, how to notify Anvisa, etc.): The company recommends not to use the products under suspicion of diversion and to arrange a return according to Alert message issued to customers who received the diversion lot and other lots under suspicion of diversion. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 06/04/2018 - Date of notification notice to Anvisa: 04/05/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: (...) Art. 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...)

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Interruption of the use of said lot numbers, segregation thereof and information to Laboratorios B. Braun SA, for collection. The manufacturer informs that it has updated the instructions for use for the products. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 12/04/2018 - Date of notification notice to Anvisa: 04/20/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Provisions to be adopted by users of the product: 1. Inform all persons in your organization who may be considered users of this product that tubes should be inspected after collection to ensure that an acceptable collection volume has been reached and the Instructions for Use have been observed. The company recommends that you collect the sample again and / or follow the protocols of your institution if the collection volume exceeds 10% of the indicated nominal volume. 2. Complete the attached form and send it to the email BRCR@bd.com so that BD can acknowledge receipt of this notification. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 09/04/2018 - Date of notification notice to Anvisa: 03/05/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 04/23/2018 - Date of notification notice to Anvisa: 04/27/2018 "The company that owns the affected product is responsible for contacting its customers in a timely manner in order to guarantee the effectiveness of the Field Action underway.We highlight the joint responsibility of the chain of distribution and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art. 2. A holder of a product registration for health is the owner of the registration / registration of health product with Anvisa. , as well as the other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the products for health to the consumer Article 12 Distributors of health products shall forward the distribution map and other information required for the notification and execution of field actions to the registration holder in a timely manner. (...) ""

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The company directs the following actions to be taken: • Read the instructions listed in the notification. • Resign notification to all persons who need to be informed at their premises. • If any of the affected persons have transferred to another facility, contact this facility. • Archive a copy of this notification. • Review, complete, sign, and return the response attached to page 3 of the letter of intent to the DePuy Synthes seller. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa .gov.br / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 03/28/2018 - Date of notification notice to Anvisa: 04/11/2018 "The company that owns the affected product is responsible for contacting its customers in a timely manner in order to guarantee the effectiveness of the Field Action underway.We highlight the joint responsibility of the chain of distribution and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art. 2. A holder of a product registration for health is the owner of the registration / registration of health product with Anvisa. , as well as the other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the products for health to the consumer Article 12 Distributors of health products shall forward the distribution map and other information required for the notification and execution of field actions to the registration holder in a timely manner. (...) ""

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Perform the following actions prior to Elecsys Vitamin D total II measurements on all analyzers. These actions represent a step-by-step approach to improve the quality of the sample prior to measurement with the Elecsys Vitamin D total II assay and should be performed temporarily, until additional information is provided by the company: 1. Perform a thorough inspection of your pre-treatment for the correct performance of the Elecsys Vitamin D total II assay and to meet the individual specifications of the primary tube manufacturers for all tubes in use (in particular, centrifuge conditions are important and foam / bubble elimination). 2. If the problem persists in plasma samples, switch to serum. 3. If you still find the problem in plasma or serum, centrifuge again in a secondary tube for 10 min in 2000 xg before measurement with Elecsys Vitamin D total II. (use secondary tubes within accepted specifications, see operator's manual). If suggestions 1, 2 and 3 do not improve the problem, consider switching to Total Elecsys Vitamin D (code 05894913190) and contact your Roche Diagnostics Representative in Brazil. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 04/13/2018 - Date of notification notice to Anvisa: 04/27/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Company recommendations: Continue using your system. If you need to remove the power cord from the back of the unit before doing so, do the following: 1. Turn off the system. 2. Unplug the machine from the wall If the end of the power cord system is damaged, system until a replacement cable is supplied. If you experience power problems with your unit, stop using the system and contact GEHC Service. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 08/03/2018 - Date of notification notice to Anvisa: 05/02/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Recommendations for users: 1) Distribute this notification to all users of the Spectra Optia Apheresis System within their organizations. 2) Review the supplement of the operator's manual attached to this letter with all users of the Spetra Optia Apheresis System, making it available for consultation whenever necessary. 3) Continue to use the Spectra Optia Apheresis Systems as instructed in the Operator's Manual and supplement contained in this letter. 4) Important: Fill in the receipt form (Annex II - Receipt Confirmation Form) and send it signed to the email lenita.gnochi@terumobct.com as soon as possible and before 05/31/2018. Sending this completed and signed form is essential to ensure that the information in this security alert has been received by all users. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 01/31/2018 - Date of notification notice to Anvisa: 05/02/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "