Z-0329-2025Class II

SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers...

Name: Z-0329-2025 SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers...
Creator: Wissner-Bosserhoff Gmbh
Published: 2022-07-11
License: https://open.fda.gov/license/

Wissner-Bosserhoff GmbH / initiated 2022-07-11 / Open, Classified / root cause: design

FDA source

WISSNER-BOSSERHOFF GMBH began a recall of SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198 on 2022-07-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0329-2025
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-11
Posted: 2024-11-08
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
Product code: LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
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.
Root cause tag: design
FDA 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 in commerce: 77 units
Distribution: US Nationwide distribution in the states of NC.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0329-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0329-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-08

Product code LLI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)