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.
Notas adicionales en la data
Fluorometer, for clinical use - Product Code KHO
Causa
Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.
Acción
Tosoh Bioscience sent an Urgent Recall Notification letter dated May 15, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to respond on the amount of product that was destroyed by completing the attached form and faxing it to 614-317-1941.
Customers with questions were instructed to call Tosoh Technical Support at 1-800-248-6764.
For questions regarding this recall call 614-317-1909.
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.
Notas adicionales en la data
Pump, infusion, elastomeric - Product Code MEB
Causa
There are reported incidents of leakage on the infusor and folfusor pumps at the connection of the blue winged cap and the distal male luer. investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged luer cap) and stored for a period of time, typically overnight. in addition, the reported instances of leakage.
Acción
Baxter sent an "Important Product Information" notification dated July 31, 2009, with a follow-up "Important Product Information" notification mailed on March 5, 2010. The notifications informed customers of the potential issue, and included instructions to ensure that the winged Luer cap is tightly secured after filling and priming. Customers were also instructed to follow normal clinical practices to reduce contact with any leaking medication, and to store pumps with pre-dispensed medication in a sealed pouch. If customers noticed a leak they were instructed to place the pump in a plastic bag, quarantine the device and call Baxter's Corporate Product Surveillance at 1-800-437-5176 for further instructions. Customers were asked to return the attached reply form via FAX to 1-847-270-5457. If customers further distributed the affected product they were instructed to forward the notification to other facilities. Customers with questions were instructed to call 1-800-933-0303.
For questions regarding this recall call 224-270-4667.
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 became aware of an incident at a va medical center facility in the us in which a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 nuclear medicine system.
Acción
GE sent an Urgent Medical Device Correction letter dated June 17, 2013 to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to labeling. Also the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment. GE notified customers again on July 03, 2013, via Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone call. Customers were instructed to cease using the affected system until GE Healthcare Field Engineer can complete an inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.
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.
Notas adicionales en la data
Pump, infusion, elastomeric - Product Code MEB
Causa
There are reported incidents of leakage on the infusor and folfusor pumps at the connection of the blue winged cap and the distal male luer. investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged luer cap) and stored for a period of time, typically overnight. in addition, the reported instances of leakage.
Acción
Baxter sent an "Important Product Information" notification dated July 31, 2009, with a follow-up "Important Product Information" notification mailed on March 5, 2010. The notifications informed customers of the potential issue, and included instructions to ensure that the winged Luer cap is tightly secured after filling and priming. Customers were also instructed to follow normal clinical practices to reduce contact with any leaking medication, and to store pumps with pre-dispensed medication in a sealed pouch. If customers noticed a leak they were instructed to place the pump in a plastic bag, quarantine the device and call Baxter's Corporate Product Surveillance at 1-800-437-5176 for further instructions. Customers were asked to return the attached reply form via FAX to 1-847-270-5457. If customers further distributed the affected product they were instructed to forward the notification to other facilities. Customers with questions were instructed to call 1-800-933-0303.
For questions regarding this recall call 224-270-4667.
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 became aware of an incident at a va medical center facility in the us in which a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 nuclear medicine system.
Acción
GE sent an Urgent Medical Device Correction letter dated June 17, 2013 to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to labeling. Also the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment. GE notified customers again on July 03, 2013, via Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone call. Customers were instructed to cease using the affected system until GE Healthcare Field Engineer can complete an inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.
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 became aware of an incident at a va medical center facility in the us in which a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 nuclear medicine system.
Acción
GE sent an Urgent Medical Device Correction letter dated June 17, 2013 to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to labeling. Also the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment. GE notified customers again on July 03, 2013, via Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone call. Customers were instructed to cease using the affected system until GE Healthcare Field Engineer can complete an inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Pump, infusion - Product Code FRN
Causa
Plum a+ infusers have the potential for the distal (occlusion) press sensor pin to break. the distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. a broken distal pin can only be detected via a visual inspection of the distal pressure pin. a broken.
Acción
Hospira sent an Urgent Device Field Correction letter dated February 1, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter recommends that facilities immediately visually inspect their Plum a+ devices to determine if the distal pressure pin is broken or damaged via instructions included in the letter. If a broken or damaged distal pressure pin is observed, remove the device from service and contact Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM, CST) to report the issue. If the return of defective pumps significantly impairs a facility's ability to operate normally, Hospira will provide loaner pumps. The letter also encourages customers to insert cassettes into pumps in accordance with the instructions found in the operator's manual. Customers were asked to complete the attached reply form and return it via fax to the number on the form. Customers with questions were instructed to call 1-800-441-4100 or 1-800-241-4002, option 4.
The letter also asked direct accounts that further distributed the pumps notify their customers of the URGENT DEVICE FIELD CORRECTION and ask them to contact Stericycle at 1-866-201-9068 to receive a reply form..
For questions regarding this recall call 800-441-4100,
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.
Factory testing on da vinci si surgical systems may not be in compliance with ul standards as one of the testing devices was found to be working incorrectly.
Acción
Intuitive Surgical sent an Urgent Device Correction notice dated July 15, 2013, to all affected customers by Federal Express.The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all affected personnel were fully informed of the notification and that the notification should be forwarded to other managers within their facility. Customers were also instructed to complete and return the attached Acknowledgment Form to acknowledge receipt of the notification. Customers with questions were instructed to call Customer Service at 800-876-1310, Option 3.
For questions regarding this recall call 408-523-2244.
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.
Notas adicionales en la data
Pump, infusion, elastomeric - Product Code MEB
Causa
There are reported incidents of leakage on the infusor and folfusor pumps at the connection of the blue winged cap and the distal male luer. investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged luer cap) and stored for a period of time, typically overnight. in addition, the reported instances of leakage.
Acción
Baxter sent an "Important Product Information" notification dated July 31, 2009, with a follow-up "Important Product Information" notification mailed on March 5, 2010. The notifications informed customers of the potential issue, and included instructions to ensure that the winged Luer cap is tightly secured after filling and priming. Customers were also instructed to follow normal clinical practices to reduce contact with any leaking medication, and to store pumps with pre-dispensed medication in a sealed pouch. If customers noticed a leak they were instructed to place the pump in a plastic bag, quarantine the device and call Baxter's Corporate Product Surveillance at 1-800-437-5176 for further instructions. Customers were asked to return the attached reply form via FAX to 1-847-270-5457. If customers further distributed the affected product they were instructed to forward the notification to other facilities. Customers with questions were instructed to call 1-800-933-0303.
For questions regarding this recall call 224-270-4667.
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.
Notas adicionales en la data
Suture, surgical, absorbable, polydioxanone - Product Code NEW
Causa
Riverpoint medical is recalling pgla surgical suture (vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.
Acción
Riverpoint sent an Urgent Medical Device Recall letter in December 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to review their inventory and immediately quarantine the product in question, if found. In addition, if they have further distributed the recalled product, the consignees were advised to identify their customers and notify them of this product recall. All affected product is to be returned to Riverpoint Medical. Consignees were asked to call 503-517-8001 to return recalled product and request a credit or replacement.
For questions regarding this recall call 503-517-8001.
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.
Notas adicionales en la data
System, x-ray, mobile - Product Code IZL
Causa
Carestream health inc. is conducting a recall for the column end cover present on the drx revolution mobile x-ray system due to the cover dislodging from the column.
Acción
The firm, Carestream Health Inc., sent a "URGENT: Medical Device Recall" letter dated June 17, 2013 via courier service to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that there is no opportunity for interference between the End Cover and potential obstructions as the column is descending. Carestream will deploy a field service representative to apply a warning label to the column, and to provide an addendum to the Safety and Regulatory Information manual. Your Carestream service representative will contact you to answer any questions and schedule a visit as soon as possible.
If you have any questions or concerns, please contact the Carestream Customer Care Center at 1-800-328-2910 from 8am through 8pm.
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 lps lower extremity dovetail intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.
Acción
On 7/11/13, URGENT MEDICAL DEVICE RECALL NOTIFICATIONS were sent to consignees: Depuy Distributors, hospitals, and surgeons. End-user Hospital Customers will submit reconciliation forms to DePuy. Possible clinical implications of device failure are stated in these notifications, including poor mechanics and loss of function, pain, component dislocation, adverse tissue reaction, bone damage, potential need for revision surgery and the risks associated with this type of surgery. A patient letter will be included with the surgeon letter to assist in surgeon's notification and discussion with patients.
The devices will be returned to DePuy Warsaw through the normal DePuy Returns process, to attention of Returns and marking H13-13 on the outside of the box.
If a patient presents with a fractured LPS" Lower Extremity Dovetail Intercalary component with well-fixed proximal and distal stems and the surgeon determines LPS" Lower Extremity Dovetail Intercalary component is the best treatment option, DePuy plans to make the LPS" Lower Extremity Dovetail Intercalary component available through authorized approvals.
Directions on how to purchase the component are provided in the Recall Communications.
Any questions or concerns about the recall, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8am-5pm EDT)
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.
Medtronic neurosurgery is recalling the medtronic preimplantation test kit because the outer carton had expiration dates that were incorrect. the date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit.
Acción
An "Urgent Field Safety Notice" recall letter dated 6/28/13 was sent to customers who purchased the Medtronic Preimplantation Test Kit, catalog number 21047, to inform them of the recall due to the incorrect outer carton expiration dates. The recall letter informed the customers of the problems and actions identified. Customers were instructed to contact the Quality Department at (805) 571-8725 for questions.
Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, 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 recall data from the U.S. and Cuba.
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.
Factory testing on da vinci si surgical systems may not be in compliance with ul standards as one of the testing devices was found to be working incorrectly.
Acción
Intuitive Surgical sent an Urgent Device Correction notice dated July 15, 2013, to all affected customers by Federal Express.The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all affected personnel were fully informed of the notification and that the notification should be forwarded to other managers within their facility. Customers were also instructed to complete and return the attached Acknowledgment Form to acknowledge receipt of the notification. Customers with questions were instructed to call Customer Service at 800-876-1310, Option 3.
For questions regarding this recall call 408-523-2244.
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.
Factory testing on da vinci si surgical systems may not be in compliance with ul standards as one of the testing devices was found to be working incorrectly.
Acción
Intuitive Surgical sent an Urgent Device Correction notice dated July 15, 2013, to all affected customers by Federal Express.The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all affected personnel were fully informed of the notification and that the notification should be forwarded to other managers within their facility. Customers were also instructed to complete and return the attached Acknowledgment Form to acknowledge receipt of the notification. Customers with questions were instructed to call Customer Service at 800-876-1310, Option 3.
For questions regarding this recall call 408-523-2244.
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.
Factory testing on da vinci si surgical systems may not be in compliance with ul standards as one of the testing devices was found to be working incorrectly.
Acción
Intuitive Surgical sent an Urgent Device Correction notice dated July 15, 2013, to all affected customers by Federal Express.The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all affected personnel were fully informed of the notification and that the notification should be forwarded to other managers within their facility. Customers were also instructed to complete and return the attached Acknowledgment Form to acknowledge receipt of the notification. Customers with questions were instructed to call Customer Service at 800-876-1310, Option 3.
For questions regarding this recall call 408-523-2244.
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.
Siemens initiate this recall due to a potential issue when using the sdis matching rules of the syngo dynamics information system version 9.5 or va10a with modality device configured to end study at association close. images or dicom sr objects sent from a modality device to syngo dynamics may not be saved when the modality is configured at syngo dynamics to end study at association close, and whe.
Acción
Siemens sent a Customer Safety Advisory Notice dated June 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
1) With sDIS implemented, use the DICOM Modality List (DMWL), without sDIS matching rules enabled OR 2) Do not implement sDIS.
Update instructions were also provided.
The reported issue will be resolved in a modification to syngo Dynamics version 9.5 and syngo Dynamics VA10A which will be released in the near future.
We regret any inconvenience that this may cause , and we thank you in advance for your understanding.
For further questions please call (610) 219-6300.
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.
Siemens issued a field safety notice about the potential hazard to patients or operators when using the function "table top float" of the axiom aristos mx. when repositioning a patient lying on the table top and releasing the table top, it is possible that the fingers of the patient or operator are between the table top and the detector tray and if the table top is moved, the fingers can be squee.
Acción
On 6/5/13, consignees were notified by letter of a "Field Safety Notice" and received instructions about how to avoid the potential risk of this issue while using the device. Siemens also rolled out a modification of AXIOM Aristos MX that will avoid these potential injuries in the future.