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Recall Observatory FDA recall evidence

Device product

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

Z-0329-2025

July 11, 2022

Class II

Product summary

Firm
WISSNER-BOSSERHOFF GMBH
Event
Event 95490
Status
Ongoing
Classification
Class II
Quantity
77 units
Official record key
device-enforcement:Z-0329-2025

Official wording

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.

Code information: 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

Distribution pattern: US Nationwide distribution in the states of NC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.