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
Industrial x-ray - Product Code RBS
Cause
Higher than published scatter around the probe head when testing some samples. at the point the customer would interact directly with the instrument (trigger position), most readings were lower. however, measurements around the probe head were higher particularly on samples know to be highly scattering (plastics, soils) with minimal increases on high density samples (steel, aluminum).
Action
Olympus Scientific Solutions planned action:
1. Notify product managers as to potential issues
2. Distribute new table and notice to instrument owners 30 JUL 15
3. Post new table on website for access 15 JUN 15
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
Device, surgical, cryogenic - Product Code GXH
Cause
The expiration date on the outer box label and the pouch label for the iovera smart tip product is incorrect. instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.
Action
Myoscience sent an Urgent Medical Device Correction letters dated July 1, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine any affected product at their site. Myoscience will make arrangements to either correct the incorrect expiation date label or remove the product and replace it with correctly labeled product immediately.
Question or concerns may be directed to Customers Service at 510-933-1500.
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
Pump, infusion, insulin - Product Code LZG
Cause
Omnipods¿ (pods) have a higher rate of failure causing:
cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the pdm and pod will not deliver insulin.
Action
The firm, Insulet Corporation, sent an "URGENT: Voluntary Device Recall" letter dated 7/13/2015 to each consignee/customer via Email notification (where possible) on 7/13/15 as well as Federal Express. Customers not responding to the email or Federal Express will receive follow up phone calls. The letter described the product, problem and actions to e taken. The customers were instructed to do the following: If you have Pods from any of these lots, set them aside, we will replace them at no charge; arrange for return and replacement by choosing one of the following methods:
1. Complete the online form at https://www.myomnipod.com/podinfo (fastest method).
2. Return the enclosed reply card by mail or fax to 1-855-407-3729.
3. Contact Insulet Customer Care by calling 1-855-407-3729 (any time day or night).
If you do not have any unused Pods form these lots, reply using one of the methods above.
If you have any question, contact Acting VP RA/QA at 978-600-7000.
EXPANDED RECALL:
Insulet Corp. issued on 11/2/15 the URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes problem of that certain lots of the pod's needle failed to deploy or there is a delay in the deployment of the needle. Customers not responding to the email or Federal Express will receive additional mailing and/or follow up phone calls. Call Customer Care at 1-855-407-3729 if you have any questions regarding this Field Safety Notification
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
Pump, infusion, insulin - Product Code LZG
Cause
Omnipods¿ (pods) have a higher rate of failure causing:
cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the pdm and pod will not deliver insulin.
Action
The firm, Insulet Corporation, sent an "URGENT: Voluntary Device Recall" letter dated 7/13/2015 to each consignee/customer via Email notification (where possible) on 7/13/15 as well as Federal Express. Customers not responding to the email or Federal Express will receive follow up phone calls. The letter described the product, problem and actions to e taken. The customers were instructed to do the following: If you have Pods from any of these lots, set them aside, we will replace them at no charge; arrange for return and replacement by choosing one of the following methods:
1. Complete the online form at https://www.myomnipod.com/podinfo (fastest method).
2. Return the enclosed reply card by mail or fax to 1-855-407-3729.
3. Contact Insulet Customer Care by calling 1-855-407-3729 (any time day or night).
If you do not have any unused Pods form these lots, reply using one of the methods above.
If you have any question, contact Acting VP RA/QA at 978-600-7000.
EXPANDED RECALL:
Insulet Corp. issued on 11/2/15 the URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes problem of that certain lots of the pod's needle failed to deploy or there is a delay in the deployment of the needle. Customers not responding to the email or Federal Express will receive additional mailing and/or follow up phone calls. Call Customer Care at 1-855-407-3729 if you have any questions regarding this Field Safety Notification
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.
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
Ferritin, antigen, antiserum, control - Product Code DBF
Cause
Asfotase alfa (strensiq) interferes with certain tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Action
The firm TOSOH Bioscience Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 23, 2018 to affected customers. The letter described the product, problem and action to be taken. The customers were instructed to do the following:
*Based on our revised labeling, the assays identified in Table 1 should not be used for patients who are being treated with Asfotase Alfa.
" For patients that are being treated with Asfotase Alfa, use an alternative test method that does not utilize alkaline phosphatase technology.
" Inform all medical professionals that assays utilizing alkaline phosphatase-based technologies must not be used for patients receiving Asfotase Alfa treatment. Continue to use the assays listed in Table 1 for any patients who are not receiving Asfotase Alfa treatment.
" Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification via Fax: 1-650-636-8651, Email: biorecallresponse@tosoh.com or Regular mail: 3600 Gantz Rd., Grove City, OH 43123.
" Maintain this notification with your laboratory records and forward this information to others who may have received this product.
" If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764.
Should you have any questions regarding this medical device recall, please feel free to call (800) 248-6764 or email: bernadette.oconnell@tosoh.com. Monday - Friday, from 9:00 AM to 5:00 PM (PST).
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
Pump, infusion - Product Code FRN
Cause
Channel error code is displayed on the pc unit with an audio and visual alarm, and on the syringe module. after the error is cleared on the pcu, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.
Action
An Urgent Medical Device Recall Notification letter was sent on 7/20/15 to customers who purchased the Alaris Syringe Module (Model 8110) to inform them that CareFusion has identified an issue with the Alaris Syringe module manufactured between March 2014 through September 2014. The letter informs customers of the problems identified and the actions to be taken. CareFusion will replace the syringe drive train assembly on the affected units and adjust, if required. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Customers are instructed to contact CareFusion Support Center (888-562-6018, 7am-4pm PT, M-F, supportcenter@carefusion.com) for recall related questions. Customers are instructed to contact Customer Advocacy (888-812-3266, 24hrs/day, 7days/wk, customerfeedback@carefusion.com) for adverse event reports. Customer are instructed to contact Technical Support (888-812-3229, 6am-5pm PT, M-F, dl-us-inf-techsupport@carefusion.com) for technical questions. Customers are instructed to complete and return the enclosed customer response card to expedite the corrective action process.
A urgent recall letter for the expansion of the affected units was sent on 10/15/15 to inform customers of the expanded recall. The letter informs customers that the firm has identified an issue with the Alaris Syringe module model 8110 after receiving reports of customers experiencing an channel error on the Alaris Syringe module Model 8110. The letter informs customers that the recall is an expansion of affected units outlined in the CareFusion recall previously issued on 7/20/15. The letter provides the customers with the affected units, issue, potential risk, and actions to be taken.
The corrective action for the expanded serial numbers will not change. The affected Alaris Syringe modules will be remediated with a hardware inspection and an adjustment, if required. CareFusion will contact all affected c
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
Unit, x-ray, extraoral with timer - Product Code EHD
Cause
Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
Action
The firm, Panoramic Corporation, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 7/17/2015 via certified mail to customers on 7/20/2015, with response forms for customers to complete and return. The firm previously issued "IMPORTANT SERVICE BULLETIN" notices in 2003 and 2008 via FED-EX. The letter describes the product, problem and actions to be taken. The customers are instructed to select to use several options including replacing the failing part with one containing the safety feature, or trading in their machine for a newer one; discontinue using the devices immediately regardless the option you select, and complete and return the attached response card via email to recall@pancorp.com or fax to 260-489-5683. If the machine has been sold or donated to another dental outfit, the customer should notify Panoramic so that they can update their records. When the customer is reached, the firm will confirm whether or not the machine is still in service.
Customers with questions may contact 800-654-2027 Monday through Thursday 8:00 AM to 6:00 PM and Friday 8:00 AM to 5:00 PM EST to discuss these options and determine which is best for their practice.
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
Camera, television, surgical, without audio - Product Code FWB
Cause
Tthe medical monitor has either not turned on or has lost image during clinical use.
Action
Sony Corporation sent an URGENT: MEDICAL DEVICE FIELD ACTION field letter dated January 13, 2015. Customers are asked to affix the warning sticker to the rear of the monitor and place the adhesive seal over the AC inlet. If the firm does not possess an AC adaptor (AC-110MD) for each of the affected monitors, stop using the monitor and take the monitor out of service until the permanent corrective action described below is implemented.SEL will be replacing the power board of all affected units with a redesigned power board that does not exhibit the appropriate failure mode. Questions can be directed to 866-789-SONY (7669) between 8:00 am and 8:00 pm Monday through Friday.
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.
Ventricular packing: lv software programming versions for biotronik crt-p and crt-d devices are recalled because they are not approved for use in the us.
Action
BIOTRONIK sent the Important Product Information letter and the Acknowledgement of Important Product Information Form, dated June 20, 2015, to affected physicians with the following recommendations:
-Review programming settings for your patients with CRT-P or CRT-D devices.
-If you have a patient with a device programmed to Ventricular pacing: LV, arrange to have the patients device reprogrammed to an appropriate approved mode (i.e. "Ventricular pacing: RV" or "Ventricular pacing: BiV").
-Physicians are requested to sign the Acknowledgement of Important Product Information Form and immediately fax to 800-913-6993 or email to UScompliance@biotronik.com.
BIOTRONIK'S representative will update your programmer with approved 1502.U programmer software. Following this update, the Ventricular pacing: LV feature will no longer be available. However, a device previously programmed with
"Ventricular pacing: LV will remain programmed in this mode unless and until the pacing mode setting is changed.
If you have any questions concerning this Important Product Information, please contact the BIOTRONIK Technical Services Department:
Telephone: 1-(800) 284-6689 (24-hour service)
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.
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.
Saw head separated from the drive unit or began to come loose.
Action
DePuy Synthes sent an " Urgent Notice Medical Device Recall (Removal) letter dated July 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
ACTION REQUIRED:
Our records show that your facility has the affected product(s) subject to this removal. The Anspach Effort, on behalf of DePuy Synthes asks that you review your inventory and immediately remove any affected BPLII Battery Oscillator devices from stock. In addition to this letter, your DePuy Synthes Sales Consultant has been provided with new product(s) to immediately replace the affected product(s).
If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your DePuy Synthes Sales Consultant.
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
5 issues. fast get ready incorrectly enabled during service procedures. contrast annotation missing for some images when manual contrast was administered. dot artifact present, intermittently, after startup. heart rate measured value incorrectly remains constant for some heart rate change conditions. doseright incorrectly enabled when the exam card specified disabling doseright. tube heat predict.
Action
On 2/5/2015 the firm sent Customer Information Letters to their customers.
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
5 issues. fast get ready incorrectly enabled during service procedures. contrast annotation missing for some images when manual contrast was administered. dot artifact present, intermittently, after startup. heart rate measured value incorrectly remains constant for some heart rate change conditions. doseright incorrectly enabled when the exam card specified disabling doseright. tube heat predict.
Action
On 2/5/2015 the firm sent Customer Information Letters to their customers.
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
5 issues. fast get ready incorrectly enabled during service procedures. contrast annotation missing for some images when manual contrast was administered. dot artifact present, intermittently, after startup. heart rate measured value incorrectly remains constant for some heart rate change conditions. doseright incorrectly enabled when the exam card specified disabling doseright. tube heat predict.
Action
On 2/5/2015 the firm sent Customer Information Letters to their customers.
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
5 issues. fast get ready incorrectly enabled during service procedures. contrast annotation missing for some images when manual contrast was administered. dot artifact present, intermittently, after startup. heart rate measured value incorrectly remains constant for some heart rate change conditions. doseright incorrectly enabled when the exam card specified disabling doseright. tube heat predict.
Action
On 2/5/2015 the firm sent Customer Information Letters to their customers.
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
Template - Product Code HWT
Cause
The markings on the distal face of the instruments are mis-oriented by 180¿. this includes anterior and posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. the cut block is not symmetric, so correct orientation of the instrument in the a/p direction is critical to making proper anterior, posterior, and chamfer cuts to fit the femoral implant.
Action
DJO Surgical sent an " Urgent Field Safety Notice" dated June 30, 2015, to the affected customer. The recalling firm requested the customer return the affected product for a replacement. For further questions, please call (512) 834-6302.
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
Test, time, prothrombin - Product Code GJS
Cause
Certain lots of pt/inr cartridges may generate a higher than typical number of pt/inr star outs potentially delaying the generation of patient results for pt/inr.
Action
Abbott Point of Care sent a recall letter dated June 15, 2015 via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the enclosed Business Reply Card (BRC). A Proof of Destruction From (FG-4533 in included with letter and is required to be returned to APOC as part of the credit process. Customers with questions were instructed to contact APOC Technical Support at 800-366-8020, Option 1 or their APOC representative.
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
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Cause
The manufacturer, b. braun medical france, received endotoxin test results that are out of specification for the peelable sheath (a1537).
Action
An Urgent Medical Device Recall letter, dated 6/16/2015 was sent to the 2 consignees via express mail. The letter explained the issue and requested the hospital review their inventory for the affected model and lot. If any quantities of the lot remained in inventory, the product was to be returned to BIS. A BIS sales representative will personally visit each account and complete an inventory sheet. Customers with questions can contact Paul O-Connell, President at 1-847-274-0097
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
Needle, aspiration and injection, disposable - Product Code GAA
Cause
Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
Action
Cadence issued the recall letter, specific to the customer dated 7/9/15 via registered mail on July 17, 2015. Accounts are requested to Recalled products must not be used.
2. Locate and quarantine all affected products.
3. Contact Cadence Science, Inc. using the Response Form provided.
4. If this information is received by a dealer, wholesaler, or distributor/reseller that distributed any of these products to other facilities, then notify their customers of this action so that those customers can locate and remove all affected products. Any questions contact: Phone: 401-942-1031
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
Needle, aspiration and injection, disposable - Product Code GAA
Cause
Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
Action
Cadence issued the recall letter, specific to the customer dated 7/9/15 via registered mail on July 17, 2015. Accounts are requested to Recalled products must not be used.
2. Locate and quarantine all affected products.
3. Contact Cadence Science, Inc. using the Response Form provided.
4. If this information is received by a dealer, wholesaler, or distributor/reseller that distributed any of these products to other facilities, then notify their customers of this action so that those customers can locate and remove all affected products. Any questions contact: Phone: 401-942-1031
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, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
Cause
Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.
Action
Janssen Diagnostics, LLC sent a urgent product correction notification/customer confirmation of receipt on 5/15/2015 via Fed Ex.
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.
Potential measurement error on acuson s family ultrasound system. when repositioning the virtual touch iq region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.
Action
On June 25, 2015 Customer Safety Advisory Notification letters were sent to all affected customers by Certified mail. The letter identified the affected product, problem and actions to be taken. The Siemens Service organization coordinates the implementation of the field correction with the distributors for all countries. For questions contact your Siemens Service for 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.
Customer complaints associated with faulty brake system.
Action
Stryker Corp.sent an Urgent Medical Device Recall letter on July 21, 2015, via FedEx to all affected customers. The letter will identified the product the problem and the action needed to be taken by the customer.
Customers are instructed the following actions:
1.Locate the units listed on the attached business reply form.
2.Remove these units from service. (Note: The original mattress purchased with the bed is not within scope of this action. The mattress will be compatible with your replacement option.)
3.Your Stryker Sales Representative will contact your facility to coordinate removal of the recalled beds and present replacement options.
4.Return the enclosed business reply form to your Stryker Sales Representative to confirm receipt of this notification or fax (269)488-8691 or email productfieldaction@stryker.com
5.If you have loaned or sold any of the beds listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form.
6.If you have disposed of any of the beds and they are no longer in use, please advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form.
*For additional information, please refer to the products operations and/or maintenance manuals.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
If there are any questions or concerns, please contact Stryker Customer Service (1-800-327-0770) during normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).
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
Ventilator, continuous, facility use - Product Code CBK
Cause
Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal volume control plus (vc+) mode with active humidification. this situation may potentially lead to respiratory compromise if not recognized.
Action
Consignees will be notified via letter on July 17, 2015. No products will be returned, the reconfiguration of affected ventilators will occur at customer sites.