Recall Z-1831-2024 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Medical Systems USA
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
| Date | May 16, 2024 (initiated Apr 15, 2024) |
| Status | Open, Classified |
| Reason | The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels. |
| Root cause | Under Investigation by firm |
| Action | Consignees received an "URGENT MEDICAL DEVICE - Removal" email, dated 4/15/2024, notifying them of this recall event. Consignees are asked to examine their inventory to identify if they possess any affected devices and all consignees are asked to return the provided Response Form via email to identify where affected devices are located. Consignees that report having any affected devices will be contacted by Getinge to arrange for return of the affected device to upgrade the system's sensor panel and perform testing to ensure that leakage current is within specifications. Technical Support can |
| Quantity | 148 units (US: 5; OUS: 143) |
| Distribution | US Nationwide distribution in the states of NJ & TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133598 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, May 21, 2014 |