U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Radiation Therapy Treament Planning System - Product Code MUJ
Cause
Ray search laboratories found an issue with the dose calculation for elekta motorized wedges in ray station 3.0, 3.5 and 4.0. the error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
Action
Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, x-ray, tomography, computed - Product Code JAK
Cause
If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.
Action
Philips sent an Urgent - Medical Device Correction letter dated October. 11, 2013, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue the use of the footrest extension. Philips also, stated they will replace the old footrest extension with the current one in use. For questions contact your local Philips representative or local Philips Healthcare office.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Microgenics corp., part of thermo fisher scientific, is recalling cedia tobramycin ii assay (lot number: 60169764) due to calibration stability problem relating to two complaints received.
Action
Microgenics Corp., part of Thermo Fisher Scientific sent an Urgent Medical Device Correction letter dated Octobere 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard. Customers with questions were instructed to contact mgc@thermofisher.com. For question regarding this recall call 1-800-232-3342.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
An error was identified in the real time controller (rtc) firmware versions 3.0, 3.1, 3.2, and 3.3 used in vantage panoramic x-ray systems. the error may cause the column of the vantage panoramic x-ray unit to continue moving vertically despite the release of the movement control button (i.E. failure to stop").
Action
An URGENT MEDICAL DEVICE FIELD CORRECTION letter dated September 20, 2013 was sent to all consignees.
Letters sent to distributors include instructions on how to identify the defective units, to quarantine the machine(s), and to contact Midmark at 847-415-9739 or via- e-mail at abavuso@midmark.com. Midmark will either schedule an on-site field correction or arrange for the replacement of the affected device(s) depending on the customer's preference. Midmark further requested the distributors provide Midmark with the names, addresses, phone numbers, and e-mail addresses of any customers that purchased any defective units.
Field corrections include the upgrading of RTC firmware to revision 3.4 on the defective units and will be performed as no additional charge by Midmark personnel.
Letter sent to practitioners include instructions on how to identify the defective units, instructions on how to temporarily reduce the likelihood of the unintentional movement, and to contact Midmark at 847-415-9739 or via- e-mail at abavuso@midmark.com. Midmark will schedule an on-site field correction by upgrading the firmware to revision 3.4.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, test, blood glucose, over the counter - Product Code NBW
Cause
There is a software synchronization issue with the accu-chek combo system. in rare cases, when the manual pump option is chosen on the accu-chek aviva combo meter, there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin.
Action
The firm, Roche Diagnostics, sent an "URGENT MEDICAL DEVICE CORRECTION (UMDC)" letter dated October 29, 2013, via UPS to their consignees/customers. The letter described the product, problem and actions to be taken. The UMDC informed them of the software synchronization issue with the ACCU-CHEK Combo system that may cause a temporary under delivery of insulin. The customers were instructed to ensure they properly deliver the correction bolus when utilizing the Manual Pump option, as instructed in the Owners Booklet; and complete and return the Business Reply Card via fax to 1-877-282-0223. The Distributors were instructed to provide the UMDC to their direct customers. The HCPs were instructed to remind their patients to follow the instructions in the Accu-Chek Aviva Combo Meter Advanced Owners Booklet when utilizing Manual Pump option.
Questions about the information contained in this UMDC are directed to ACCU-CHEK Pump Support, 24 hours a day, seven days a week at 1-800-688-4578.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Peritoneal system automatic delivery - Product Code FKX
Cause
In systems with version 10.4 software initial drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). the operator can stop, but cannot bypass, the active initial drain. this is to mitigate against unintended increased intraperitoneal volume (iivp). this can cause serious problems in patients with unrelated a co-morbid condition of ascites.
Action
An IMPORTANT PRODUCT INFORMATION letter dated October 7, 2013, was sent to all affected customers.
The letter included instructions for clinicians to: 1) be aware that HomeChoice will attempt to drain the patient to empty at the beginning of therapy (Initial Drain); 2) review HomeChoice instructions for use for additional details on HomeChoice 10.4 Initial Drain Logic; 3) acknowledge your receipt of the notification by completing the attached Customer Reply Form and returning by fax to either 224-270-5457 or scanning and e-mailing it to fca@baxter.com; 3) if the recipient of the letter is a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, to forward the communication to all customers who may have received these products.
Clinical questions should be addressed to Baxter's Renal Division Clinical Helpline at 888-736-2543, option 2 (Monday - Friday, 8:00 AM - 5:00PM CST). General questions about this recall should be addressed to The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Component, external, limb, ankle/foot - Product Code ISH
Cause
Ossur inititated a voluntary recall of the a-642100 fixed offset adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.
Action
Ossur sent an "Safety Notice Voluntary Product Recall" letter dated October 29, 2013, via regular mail. Follow-up telephones are also made. The letter identified the product the problem and the actions to be taken by the customer.
¿ssur is committed to providing superior customer service and we will do our utmost to minimize any inconvenience this may cause your practice. To ensure patient safety we kindly ask you to take the following action:
" Please identify the users of each of the A-642100 adapters, see attached list.
" Also, please check your inventory for any A-642100s you may have on hand but have not fitted on users.
A follow-up phone call will be made a few days later to coordinate replacements. A new replacement component will be provided to the customer.
For further questions please call (949) 360-3634.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Laparoscope, general & plastic surgery - Product Code GCJ
Cause
Applied medical is conducting a voluntary recall of the inzii¿ 12/15mm retrieval system. during shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. the likelihood of this situation to occur and result in patient harm is highly unlikely; however, out of an abundance of caution for patient safety and a commitmen.
Action
Customer notifications of the recall began the week of 10/21/2013 via UPS overnight with letters requesting that all affected products be returned to Applied. The notification letter is dated October 21, 2013 and titled "URGENT: MEDICAL DEVICE RECALL". The notification was accompanied by a Recall Notification Confirmation Form. The letter informed customers of the recall by providing the product description with codes (Model and Lot Numbers). reason for the recall, actions to take and contact information.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
During an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of sarns" soft-flow¿ aortic cannulae and sarns" venous return cannulae.
Action
On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
During an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of sarns" soft-flow¿ aortic cannulae and sarns" venous return cannulae.
Action
On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
During an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of sarns" soft-flow¿ aortic cannulae and sarns" venous return cannulae.
Action
On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
During an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of sarns" soft-flow¿ aortic cannulae and sarns" venous return cannulae.
Action
On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Ge healthcare has recently become aware of a potential safety issue related to a spect scan procedure used for pulmonary imaging.
contact between the detector (ge healthcare discovery nm/ct 670, and/or optima nm/ct 640, and/or discovery
nm630, and/or brivo nm 615 all configurations) and the patient's elbow may occur during spect protocols using 450 angular steps in scenarios when a patients a.
Action
GE Healthcare sent an "Urgent Medical Device Correction" letter dated September 25, 2013, to all affected customers. The letter identified the product the problem and the actions to be taken by the customer.
We plan to correct all of the affected Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615 systems that were distributed
The plan for public warning is to contact all customers with an affected Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615 system by means of an Urgent Medical Device Correction letter. In the US this will be sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX). This letter will be sent to 3 titles within the affected accounts; Managers of Nuclear Medicine, Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology. A GE Healthcare Field Engineer will perform the required software update on each affected system.
Contact Information (GE Healthcare Call Center: USA or Canada 800-437-1171 and Other countries:( 262-896-2890).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The user database delivered for download contained an erroneous value. specifically the "ao" constant of the lens amo sensar ar40e is listed as "0.0" in the internal lens database of the iolmaster. the correct value is -2.420. this could lead to the implantation of lens with a wrong diopter value.
Action
The firm, Zeiss, sent an "Urgent Medical Device Correction" letter dated October 23, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to immediately update the Laser Interference Biometry (ULIB) lens constants, provided as an Attachment 1 and complete and return Attachment 2- Confirmation Form via mail to: Stericycle, Inc., 6026 Lakeside Blvd., Indianapolis, IN 46278; Attn: Zeiss IOLMaster.
If you have any questions, call the following number for assistance: 1 (866) 891-1922.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The user database delivered for download contained an erroneous value. specifically the "ao" constant of the lens amo sensar ar40e is listed as "0.0" in the internal lens database of the iolmaster. the correct value is -2.420. this could lead to the implantation of lens with a wrong diopter value.
Action
The firm, Zeiss, sent an "Urgent Medical Device Correction" letter dated October 23, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to immediately update the Laser Interference Biometry (ULIB) lens constants, provided as an Attachment 1 and complete and return Attachment 2- Confirmation Form via mail to: Stericycle, Inc., 6026 Lakeside Blvd., Indianapolis, IN 46278; Attn: Zeiss IOLMaster.
If you have any questions, call the following number for assistance: 1 (866) 891-1922.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Absorber, carbon-dioxide - Product Code BSF
Cause
Ge healthcare has recently become aware of a potential safety issue due to air leakage associated with the co2 multi absorber.
Action
GE issued an Urgent Medical Device Correction letter dated September 19, 2013, to all affected customers via Fed Ex overnight mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the affected product, isolate all affected product and return the attached form via fax to 800-535-7923. Once the information is received, customers would be contacted with an RMA and replacement information. If product was distributed further the notice should be forwarded to those customers. For questions customers should call 1-800-345-2700, option 2 followed by ooption 2. For foreign customers 1-800-932-0760, option 2.
For questions regarding this recall call 262-513-4122. GE issued a press release on 12/30/2013.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Cause
Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. the implant may skip across the hole or miss the hole during insertion.
Action
Biomet sent an Urgent Medical Device Recall Notice letter dated October 10, 2013 to all consignees. The letter identified the affected product, reason for recall, and actions to be taken. The letter stated customers will be contacted on an individual basis in an attempt to reconcile the affected product. Customers were directed to locate and remove implicated devices and fax a copy of the response form to 574-372-1683 prior to returning product. For questions call 574-372-1570.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Rigid Laryngoscope - Product Code CCW
Cause
Labeling inconsistency.
Action
Recall letters were sent to customers and distributors on 10/15/2013 via courier. The letter indicated that the consignee was to immediately discontinue use and quarantine any products with the affected catalog numbers. The letter also included a Recall Acknowledgment Form which was to be faxed back to the firm.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, nuclear magnetic resonance imaging - Product Code LNH
Cause
When not used correctly, accusorb mri products may overheat and lead to patient injury.
Action
MWT issued a letter dated 10/4/2014 via email to all distributors for further distribution to consignees. Tghe letter identified the affected product, problem and actions to be taken. Questions can be direct to info@MWT-Materials.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Vital images, inc. has found an issue in vitreacore software though internal testing. there is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in vitreacore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5.
Action
Vita Images, Inc. sent an Urgent Medical Device Recall letter on October 21, 2013, to all affected customers via USPS First class mail. The letter described the Reason for Voluntary Recall (Nature of software issue, Potential scenarios which exhibit the issue), Risk to Health (How to confirm if the Snapshots are correct), Actions to be Taken by Customer (Recommended Next Steps which includes to complete and sign the enclosed Effectiveness Check Form and send to fieldnotices@vitalimages.com or fax to 1-952-540-3717), and Actions Being Taken by Vital Images (Vital Images Contact Information: If you have questions, direct Vital Images customers and customers of Toshiba America Medical Systems (TAMS) should contact Vital Images Customer Support at +1-800-208-3005, or by e-mail to support@vitalimages.com; customers through a distributor will be contacted by that distributor).
For questions regarding this recall call 952-487-9574.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Cause
There is a possibility that the locking mechanism of the azure anterior cervical plate may fracture during or after implantation.
Action
Orthofix sent a Urgent Medical Device Recall Notification dated October 29, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Immediate Action:
1. Immediately cease any further distribution or use of the AZURE" plates.
2. Notify your surgeons and staff customers that Azure" plates cannot be used and are to be returned to Orthofix. at no cost to you, see Instructions below.
3. Please complete the attached reply form indicating that you have received this letter.
Product Return Instructions: To return the Azure plates, please follow these Instructions.
1. Check you inventory of Azura Implant Trays..
2. Complete the attached form with the quantity you are returning.
3. Contact your local Orthofix representative or Orthofix customer service
representative at 888--298-5700 for return instructions and shipment information and replacement with a different Orthofix Anterior Cervical Plate System.
.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
A problem has been detected with philips model epiq 7 ultrasound system, software version 1.0 and 1.0.1. using the international system date format may result in calculation errors in gestational age gestational age (ga) and established due date (edd).
Action
Affected customers will be notified via the Urgent-Field Safety Notice (FSN79500286), Philips Model EPIQ 7 Ultrasound system, dated 2013 October. Customers are informed that using the International System Date Format in the Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. may result in calculation errors in Gestational Age and Established Due Date (EDD). Philips will upgrade customer systems to software version 1.1, which corrects the issue, for a free of charge.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Glucose oxidase, glucose - Product Code CGA
Cause
Alere initiated a recall of cholestech ldx lipid profile-glu test cassettes, catalog number 10-991, lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. the incorrect lot # number printed was 321067.
Action
Alere initiated this recall by sending out notification letters to customers via fax, email, or direct mail. The letter titled "URGENT MEDICAL DEVICE NOTICE", dated October 23, 2013 is accompanied by a response form/Verification form. The notification informed customers of the reason for recall, product description with codes, required actions by the customers, and contact information.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Controller, foot, handpiece and cord - Product Code EBW
Cause
The recall was initiated because there is a potential for malfunction of the osseocare pro when used with the oseeocare pro ipad application software release 1.2.0.7.
Action
Bien Air Dental send and Urgent Field Safety Notice dated October 24, 2013, to all affected customers. The letter notified customers of the recall, description of the problem, description of the product (OsseoCare Pro iPad app software release 1.2.0.7), action to be taken by user, an alternative solution, and contact details. The letter was also accompanied by an acknowlegement form. Customers with questions were instructed to call 1-800-433-2436.
For questions regarding this recall call 714-282-4800.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
Cause
Terumo cardiovascular systems (terumo cvs) became aware of a customer complaint that a 15mm x 8mm gelsoft graft was received which the customer believed was a 15mm x 6mm gelsoft graft unit. the manufacturer confirmed a batch of product code 631508 was incorrectly labeled.
Action
Terumo CVS called affected consignees (via telephone)on 10/23/2013 of this device removal. Terumo CVS advised users to discontinue use and return all affected grafts in inventory. Terumo will replace or issue credit for returned grafts. Terumo provided consignees with the reason of the removal, potential hazard, and description of affected product. Terumo addressed any questions from the consignees. Consignees with questions were instructed to contact Terumo CVS Customer Service at 800-521-2818.
For questions regarding this recall call 734-741-6173.