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Open, Classified

SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198

FDA Recall Z-0329-2025 · Posted 2024-11-08

Recalling FirmWISSNER-BOSSERHOFF GMBH
Recall StatusOpen, Classified
Product CodeLLI
Date Initiated2022-07-11
Product Quantity77 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the states of NC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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