Recall Z-0986-2019 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
| Date | Mar 28, 2019 (initiated Feb 8, 2019) |
| Status | Terminated |
| Reason | Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive. |
| Root cause | Process control |
| Action | Maquet has issued an Urgent Medical Device Recall dated February 26, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that their Emergency Drives had already been inspected and replaced with a loaner Emergency Drive if found to be affected. Affected E-Drives were returned to Getinge for servicing. Upon servicing, a service technician will return the Emergency Drive to your facility. Customers were asked to complete and sign the customer response form to acknowledge receipt of the notification. If you have any |
| Quantity | 10 |
| Distribution | US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102726 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, Apr 4, 2011 |