Maquet Medical Systems USA Recall 93013
Description: Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Maquet Medical Systems USA Recall 93013 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0290-2024 |
| Event ID | 93013 |
| Event Description | Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder) |
| Product Type | Devices |
| Distribution | US Nationwide. |
| Quantity | 1022 units |
| Recall Reason | It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force. |
| Device Classification | 20231115 |
| Device Code Info | UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868 |
| Center Classification Date | 20231109 |
| Recall Initiation Date | 20231012 |
| Recalling Firm | Maquet Medical Systems USA |
| Initial Notification | Letter |
| Similar To |