SafeControl handset (a component of the Sentida bed which… recallZ-0329-2025 · Wissner-Bosserhoff GMBH · initiated Jul 11, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Wissner-Bosserhoff GMBH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0329-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 11, 2022
- Posted by the FDA
- Nov 8, 2024
- Recalling firm
- Wissner-Bosserhoff GMBH
- Quantity
- 77 units
- Product code
- LLI
- Distribution
- US Nationwide distribution in the states of NC.
Product description
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Code information (models, lots, serial 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
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- sentida 03 19-1062WISSNER-BOSSERHOFF GmbH · Bed, Therapeutic, Ac-Powered, Adjustable Home-Use1 recall0 reports
- sentida 1 19-0990WISSNER-BOSSERHOFF GmbH · Bed, Therapeutic, Ac-Powered, Adjustable Home-Use1 recall0 reports
- sentida 04 19-1152WISSNER-BOSSERHOFF GmbH · Bed, Therapeutic, Ac-Powered, Adjustable Home-Use1 recall0 reports
- sentida 5 19-1119WISSNER-BOSSERHOFF GmbH · Bed, Therapeutic, Ac-Powered, Adjustable Home-Use1 recall0 reports
- sentida 5-le 19-1155WISSNER-BOSSERHOFF GmbH · Bed, Therapeutic, Ac-Powered, Adjustable Home-Use1 recall0 reports
- sentida 6-le 19-1156WISSNER-BOSSERHOFF GmbH · Bed, Therapeutic, Ac-Powered, Adjustable Home-Use1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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