Recall Z-0926-2023 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
Cardiac Assist, Inc
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
| Date | Jan 19, 2023 (initiated Dec 5, 2022) |
| Status | Terminated |
| Reason | A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data. |
| Root cause | Software design |
| Action | On December 5, 2022, the firm notified customers through Urgent Medical Device Communication letters that a software update has been developed to address the issue of Critical Failure. The only action required by the customer will be to make their equipment available for the third-party representative from MERA to perform the update and sign off on the form once the upgrade is completed. This software update is the follow-up to the earlier recall notification on or around July 21, 2022, when customers were instructed to use a new revision of the Operations Manual. For questions regarding th |
| Quantity | 763 (US only) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183623 | LifeSPARC Pump, LifeSPARC Controller Cardiacassist, Inc., Jul 9, 2019 |