Recall Z-0329-2025
Wissner-Bosserhoff GmbH · initiated July 11, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Codes / lots: UDI/DI 4050621100401, 19-0990 UDI/DI 4050621100012, 19-1062 UDI/DI 4050621100432, 19-1152 UDI/DI 4050621100449, 19-1119 UDI/DI 4050621100470, 19-1155 UDI/DI 4050621100487, 19-1156
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0329-2025
- Initiated
- July 11, 2022
- Posted by FDA
- November 8, 2024
- Product code
- LLI – Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
- Quantity
- 77 units
- Distribution
- US Nationwide distribution in the states of NC.
- Recalling firm
- Wissner-Bosserhoff GmbH, Wickede Ruhr