The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0329-2025·Announced 2024-11-20

SafeControl Bed Handset May Move Unexpectedly After Power Restoration

The SafeControl handset component of Sentida beds may revert to an active mode after power restoration, potentially causing unintended bed movement. Consumers should ensure beds are safely positioned before power interruptions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The hazard—unintended bed movement triggered by power restoration—poses a theoretical risk of harm to patients, fitting the 'High' severity criterion for risk-of-harm products without reported injury.

Plain-English summary

Wissner-Bosserhoff GmbH is recalling the SafeControl handset, a component of the Sentida electric bed system used for positioning and adjustment. The recall affects model numbers 01-011539, 01-011541, and 01-01198. A total of 77 units were distributed in North Carolina.

When the SafeControl handset is disconnected from power and power is subsequently restored, the device automatically resets to Resident mode. In this mode, the bed's backrest, legrest, and height adjustment functions become active and can be operated. This automatic reset could cause unintended bed movement without notice to patients or caregivers.

Consumers who have purchased or are using the affected Sentida beds should contact their healthcare provider or equipment supplier about this issue. Until a solution is provided, bed users should ensure the bed is in a safe, stable position before any power interruptions occur.

The recalled product

Product
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Manufacturer
WISSNER-BOSSERHOFF GMBH
Category
Medical Device — Assistive Mobility Device
Hazard
Affected units
77

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • 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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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