SafeControl handset — Class II medical device recall Z-0329-2025
Ongoing recall by WISSNER-BOSSERHOFF GMBH, reported 2024-11-20, distributed nationwide. When the handset is disconnected from the power mains, and mains operation is restored, the handset is reset t
| Recall number | Z-0329-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | WISSNER-BOSSERHOFF GMBH, Wickede (Ruhr), N/A, Germany |
| Recall initiated | 2022-07-11 |
| Classified | 2024-11-08 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 77 units |
| UPC / GTIN / UDI-DI | 04050621100012, 04050621100401, 04050621100432, 04050621100449, 04050621100470, 04050621100487 |
| Model numbers | 01-011539, 01-011541, 01-01198 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0329-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.