FDA Medical Device Recalls (openFDA)
WISSNER-BOSSERHOFF GMBH: SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
- Recall number
- Z-0329-2025
- Recalling firm
- WISSNER-BOSSERHOFF GMBH
- Product
- SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
- Status
- Open, Classified
- Initiated
- 2022-07-11
- Posted
- 2024-11-08
- Terminated
- not on file
- 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.
- Root cause
- Device Design
- 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.
- Quantity
- 77 units
- Distribution
- US Nationwide distribution in the states of NC.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LLI
- Firm FEI
- 3015979371
- Firm city
- Wickede Ruhr
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28