FDA recall Z-0329-2025

Product

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

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.

Distribution

US Nationwide distribution in the states of NC.

Key facts

Status

Ongoing

Initiation date

2022-07-11

Report date

2024-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wickede (Ruhr), N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0329-2025