FDA Recall
Open, Classified
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Recall: Z-0329-2025
·
Initiated July 11, 2022
Recall
- Recall Number
- Z-0329-2025
- Event Number
- 95490
- Firm
- WISSNER-BOSSERHOFF GMBH Hauptstr. 4-6 Wickede (Ruhr) Germany
- FEI Number
- 3015979371
- Product Code
- LLI
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- July 11, 2022
- Posted
- November 8, 2024
Description
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
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.
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.
Distribution
US Nationwide distribution in the states of NC.
Quantity
77 units