CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report
SafeControl handset (a component of the Sentida bed recalled
Wissner-bosserhoff is recalling SafeControl handset (a component of the Sentida bed which moves and positions the bed), distributed nationwide in the US. The recall was initiated on 11 Jul 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0329-2025
- FDA event ID
- 95490
- Recalling firm
- Wissner-bosserhoff, Wickede (Ruhr), N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jul 2022
- FDA classified
- 8 Nov 2024
- Reported
- 20 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Jul 2022 | Recall initiated by company | |
| 8 Nov 2024 | Classified by FDA | +851 days |
| 20 Nov 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Where it was distributed
US Nationwide distribution in the states of NC.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the states of NC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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