Class 2 Device Recall TotalCare bed system

• Date Initiated by Firm: March 15, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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: 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.