Recall Z-0329-2025— WISSNER-BOSSERHOFF GMBH

Name: FDA recall Z-0329-2025
Creator: U.S. Food and Drug Administration
Published: 2022-07-11

Class II · Ongoing

Class II FDA medical device recall by WISSNER-BOSSERHOFF GMBH, initiated 2022-07-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm: WISSNER-BOSSERHOFF GMBH
Classification: Class II
Status: Ongoing
Initiated: 2022-07-11
Firm location: Wickede (Ruhr), N/A, Germany

Product description

SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.