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U.S. Department of Health and Human Services

Class 2 Device Recall TotalCare bed system

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  Class 2 Device Recall TotalCare bed system see related information
Date Initiated by Firm March 15, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on May 14, 2004
Recall Number Z-0761-04
Recall Event ID 28465
Product Classification Bed, Therapeutic, Ac-Powered, Adjustable Home-Use - Product Code LLI
Product Hill-Rom brand TotalCare bed system; model P1900 -remanufactured only.
Code Information All remanufactured beds distributed between August 2003 and February 2004.
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
125 E Pearl St
Batesville IN 47006
For Additional Information Contact customer service
800-445-3730
Manufacturer Reason
for Recall
A warning label, advising users not to use oxygen tents with this equipment because of the potential for a fire, was not placed on these remanufactured beds.
FDA Determined
Cause 2
Other
Action A letter dated 3/15/04 was sent to each affected consignee, with labels included, requesting that they attach them to each affected bed.
Quantity in Commerce 52
Distribution Arizona, Florida, Georgia, Nevada, Puerto Rico, Texas, Virginia and Canada.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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