Recall Z-2271-2024 ยท FQO Table, Operating-Room, Ac-Powered
Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
| Date | Jul 5, 2024 (initiated May 29, 2024) |
| Status | Open, Classified |
| Reason | The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure. |
| Root cause | Component design/selection |
| Action | On May 29, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken by the Customer: Our records indicate that you have received one or more of the ALPHAMAXX Mobile Operating Table from the affected Product Code/Part Number 1133.22F5. Please examine your inventory immediately to determine if you have any of the ALPHAMAXX Mobile Operating Table (1133.22F5) with the Product REF number listed in this notice. The device can be used in accordance with the instructions for use, with extra attention to the following: 1. The battery status is displayed on the override |
| Quantity | 73 units |
| Distribution | Domestic: KY, NC, NY, VA. International: Australia, Bulgaria, Croatia, Czech Republic, Denmark, France, Greece, Hong Kong, Ireland, Israel, Japan, Jordan, Kuwait, Mexico, New Zealand, Norway, Poland, Romania, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, United Arab Emirates, United Kin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.