Recall Z-0589-2024 ยท MWS Stabilizer, Heart
Maquet Cardiovascular, LLC
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
| Date | Dec 19, 2023 (initiated Oct 31, 2023) |
| Status | Open, Classified |
| Reason | The Positioner Arm may not tighten or lock during normal use. |
| Root cause | Component design/selection |
| Action | An URGENT MEDICAL DEVICE Removal notification letter dated 10/31/23 was sent to customers. Actions to be taken by the customer: Our records indicate that you have received the Acrobat-i Vacuum Positioner System having one or more of the lot numbers that are affected by this medical device removal. Please examine your inventory immediately to determine if you have any of the Acrobat-i Vacuum Positioner Systems with the product codes/lot numbers listed in this notice and remove these from use. Return any unused/unexpired affected product to Maquet/Getinge. Please contact Maquet/Getinge Custo |
| Quantity | 6472 units |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.