SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-01
Summary
The FDA issued a Class II for SafeControl handset (a component of the Sentida bed which moves and positions th by WISSNER-BOSSERHOFF GMBH. 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.
Details
Source
Device Recall
External ID
Z-0329-2025
Action Date
2024-11-20
Status
Ongoing
Category
device
Product Description
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Lot/Code Info: 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
Quantity Affected: 77 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-11
Company
Wickede (Ruhr), N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 242 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (WISSNER-BOSSERHOFF GMBH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does WISSNER-BOSSERHOFF GMBH have FDA actions?
This is the only FDA action we have on record for WISSNER-BOSSERHOFF GMBH in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0329-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29