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.
Extra notes in the data
System, x-ray, tomography, computed - Product Code JAK
Reason
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Action
On 3-18-2015 the firm sent Urgent Field Safety Notices 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.
Extra notes in the data
System, x-ray, tomography, computed - Product Code JAK
Reason
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Action
On 3-18-2015 the firm sent Urgent Field Safety Notices 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.
Extra notes in the data
System, x-ray, tomography, computed - Product Code JAK
Reason
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Action
On 3-18-2015 the firm sent Urgent Field Safety Notices 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.
Extra notes in the data
System, x-ray, tomography, computed - Product Code JAK
Reason
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Action
On 3-18-2015 the firm sent Urgent Field Safety Notices 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.
Needle is leaking from hub/needle cannula connection.
Action
Codman Neuro issued recall letter on 3/05/15 requested to immediately check all inventory to determine if you have affected product. Complete the Acknowledgement Form and follow the instructions to report your inventory status and return affected product for credit and replacement (if requested).
General inquiries, customer service or field action logistics - please contact Codman Neuro Quality at: CodmanProductComplaints@DPYUS.JNJ.com or 866-491-0974.
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.
Extra notes in the data
Condenser, heat and moisture (artificial nose) - Product Code BYD
Reason
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Action
Consignees were contacted by telephone on 02/19/2015.
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.
Extra notes in the data
System, x-ray, tomography, computed - Product Code JAK
Reason
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Action
On 3-18-2015 the firm sent Urgent Field Safety Notices 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.
Extra notes in the data
System, x-ray, tomography, computed - Product Code JAK
Reason
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Action
On 3-18-2015 the firm sent Urgent Field Safety Notices 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.
Extra notes in the data
Introducer, syringe needle - Product Code KZH
Reason
The syringe carrier is missing components: a damper and spring.
Action
Recall letters were issued to customers via FedEx. The letter instructed the customer to check their shelves for the product and specific lot number and to visually inspect (pictures included in letter of a correctly assembled device and one with the missing spring & damper) the device if they have the affected lot. A form was included which was to be filed out and returned.
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.
Extra notes in the data
Introducer, Catheter - Product Code DYB
Reason
The tip of the stiffened cannula might break during use
and remain in the patient.
Action
Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand.
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.
Extra notes in the data
System, x-ray, tomography, computed - Product Code JAK
Reason
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Action
On 3-18-2015 the firm sent Urgent Field Safety Notices 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.
Extra notes in the data
System, x-ray, tomography, computed - Product Code JAK
Reason
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Action
On 3-18-2015 the firm sent Urgent Field Safety Notices 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.
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.
Extra notes in the data
System, nuclear magnetic resonance imaging - Product Code LNH
Reason
The gradient output supervision was permanently turned off on the magnetom system, meaning that gradient outputs could exceed iec60601-2-33 limits and peripheral nerve stimulation could occur.
Action
A Customer Safety Advisory Notice, dated March 6, 2015, was sent to end users to inform them of the potential issue and what measures were being taken to mitigate possible risks.
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.
Extra notes in the data
Stylet, tracheal tube - Product Code BSR
Reason
Vital signs colorado (dba carefusion) is recalling vital signs lightwand stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
Action
Customers were notified on 3/13/15 via letter to perform an inventory, complete and return the Recall Response Form within 15 days, and to destroy the product on site (do not return to CareFusion).
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.
Extra notes in the data
Stylet, tracheal tube - Product Code BSR
Reason
Vital signs colorado (dba carefusion) is recalling vital signs lightwand stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
Action
Customers were notified on 3/13/15 via letter to perform an inventory, complete and return the Recall Response Form within 15 days, and to destroy the product on site (do not return to CareFusion).
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.
Extra notes in the data
Ventilator, continuous, facility use - Product Code CBK
Reason
Reports of inaccurate low flow readings. monitored inspiratory tidal volume (vti) and expiratory tidal volume (vte) measurements from the pediatric flow sensor are reporting out of specification low compared to the actual delivered volumes being administered to the patient.
Action
Spacelabs started mailing the Urgent Medical Device Correction- Pediatric Flow Sensor kit, PN: 376-0561-00 used with Spacelabs 700 and 900 series ventilators letter, dated 17 March 2015, via priority service to all US customers.
Spacelabs will be emailing the customer letter (translated as necessary) to all international subsidiaries and distributors of record on March 20, 2015.
Customers are asked to dispose of all pediatric flow sensors purchased from Spacelabs (even if they shipped outside of the time frame in which affected product shipped).
Customers are requested to complete and return the Business Reply Form to Spacelabs Healthcare either by fax to Global Tech Support at 425-363-5758
or scan the form and email to techsupport@spacelabs.com
Spacelabs will send you at no charge replacement pediatric flow sensors (376-0561-01) for all Spacelabs pediatric flow sensors you purchased. These NEW sensors will be marked with a "-01" molded into the body so you can tell the difference between the old sensors and the new ones.
For additional information or technical assistance, please contact:
Technical Support
Spacelabs Healthcare, Inc.
35301 SE Center Street
Snoqualmie, WA 98065
1-800-522-7025 and select 2 for Technical Support
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.
Extra notes in the data
Orthopedic tray - Product Code OJH
Reason
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Action
Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
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.
Smith & Nephew sent an Urgent Product Recall notification letter dated May 15, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, quarantine immediately and return to the address listed on the inventory Return Certification Form.
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.
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. risk of delay in surgery.
Action
Zimmer Biomet sent an Urgent Medical Device Recall (REMOVAL) LOT SPECIFIC notifications dated December 19, 2016, to the affected distributors and Risk Managers and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Risk Manager Responsibilities:
1. Review this notification and ensure affected personnel are aware of the contents.
2. Assist your Zimmer Biomet sales representative quarantine all affected product.
3. Your Zimmer Biomet sales representative will remove the affected product from your facility.
4. Complete Attachment 1 Certificate of Acknowledgement.
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com.
b. Retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilities documentation.
5. If after reviewing this notice you have further questions or concerns please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com.
Distributor Responsibilities
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification
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.
Extra notes in the data
Introducer, Catheter - Product Code DYB
Reason
The tip of the stiffened cannula might break during use
and remain in the patient.
Action
Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand.
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.
Extra notes in the data
Drape, surgical - Product Code KKX
Reason
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
Action
Firm issued field safety notice to all customers on March 16, 2015. Field safety notice includes acknowledgement form to be returned to recalling firm. A second letter was sent on May 12, 2015 to inform users that the date that the drape product unaffected by the issue will not be availalble untisl October/November 2015, not May 2015 as stated in the original communication.
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 component failure resulting in inoperability.
Action
Smith & Nephew sent an Urgent Product Recall notification letter dated May 15, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, quarantine immediately and return to the address listed on the inventory Return Certification Form.
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.
Extra notes in the data
Tomographic imager combining emission computed tomography with nuclear magnetic resonance - Product Code OUO
Reason
The firm was notified that the failure of the ups accessory devices used in conjunction with computed tomography x-ray systems and diagnostic imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
Action
On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction 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.
The firm was notified that the failure of the ups accessory devices used in conjunction with computed tomography x-ray systems and diagnostic imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
Action
On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers.