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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom 70 SemiElectric Bed

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 Class 2 Recall
HillRom 70 SemiElectric Bed
see related information
Date Posted January 16, 2009
Recall Status1 Terminated on December 31, 2009
Recall Number Z-0506-2009
Recall Event ID 50181
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in the home care environment.
Code Information Serial numbers HC100001 through HC101261.
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
125 E Pearl St
Batesville, Indiana 47006
For Additional Information Contact Steven S. Hollingsworth
812-934-6727
Manufacturer Reason
for Recall
Failure, mechanical: If the bed mechanism is cranked downward when the bed is already in its lowest position, the springs may cause the bed to rise suddenly if the bed is empty, more slowly if occupied by a patient, or when the patient exits the bed. For further information, please contact Hill-Rom, Inc. at 800-445-3720.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Consignees were notified of the problem by letter dated 11/11/08 and instructed to position the bed at least 3 inches above the lowest bed position in order to prevent the problem, and then to only use the pendant electronic controls to raise and lower the head and foot sections of the bed, until Hill-Rom can repair the bed. The letter was entitled "Urgent Medical Device Correction.".
Quantity in Commerce 567
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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