FDA Medical devices recall ·
SafeControl handset (a component of the Sentida bed which moves and… recall
- Recall number
- Z-0329-2025
- Date
- (initiated July 11, 2022)
- Company / brand
- Wissner-Bosserhoff Gmbh
Hauptstr. 4-6, Wickede (Ruhr), N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 77 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide distribution in the states of NC.
States: North Carolina
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0329-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.