Recall Z-0329-2025 ยท LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
WISSNER-BOSSERHOFF GMBH
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
| Date | Nov 8, 2024 (initiated Jul 11, 2022) |
| Status | Open, Classified |
| Reason | When the handset is disconnected from the power mains, and mains operation is restored, the handset is reset to the preset Resident mode. In this mode, the backrest, legrest, and height adjustment can be moved. |
| Root cause | Device Design |
| Action | Wissner-bosserhoff issued an Urgent safety information notice along with supplement use instructions notice to its sole US consignee on 07/11/2022. The notice explained the problem, risk to patient, and requested the user update the IFU for the device. Distributors were directed to notify their customers. |
| Quantity | 77 units |
| Distribution | US Nationwide distribution in the states of NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.