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U.S. Department of Health and Human Services

Class 2 Device Recall SafeControl Handset

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 Class 2 Device Recall SafeControl Handsetsee related information
Date Initiated by FirmJuly 11, 2022
Date PostedNovember 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0329-2025
Recall Event ID 95490
Product Classification Bed, therapeutic, ac-powered, adjustable home-use - Product Code LLI
ProductSafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Code Information 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
FEI Number 3015979371
Recalling Firm/
Manufacturer		 WISSNER-BOSSERHOFF GMBH
Hauptstr. 4-6
Wickede (Ruhr) Germany
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionWissner-bosserhoff issued an Urgent safety information notice along with supplement use instructions notice to its sole US consignee on 07/11/2022. The notice explained the problem, risk to patient, and requested the user update the IFU for the device. Distributors were directed to notify their customers.
Quantity in Commerce77 units
DistributionUS Nationwide distribution in the states of NC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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