Medical device recalls Moderate risk

WISSNER-BOSSERHOFF GMBH recalls SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-01…

Recall date
July 11, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0329-2025
FDA classification
Class II
Brand / firm
WISSNER-BOSSERHOFF GMBH
Sold / distributed
US Nationwide distribution in the states of NC.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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