Reported Nov 20, 2024 · Ongoing

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

Wissner-Bosserhoff GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: WISSNER-BOSSERHOFF GMBH · Hauptstr. 4-6 · Wickede (Ruhr), N/A · N/A

Is this the product you have?

  • SafeControl handset (a component of the Sentida bed which moves and positions the bed)
  • Model Numbers
    • 01-011539
    • 01-011541
    • 01-01198
Lot codes and dates
    • 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
Amount recalled
77 units

Where it was sold

  • Nationwide
  • NC

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:36 PM UTC

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