Class 2 Device Recall TotalCare

• Date Initiated by Firm: June 28, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on December 14, 2004
• Recall Number: Z-1090-04
• Recall Event ID: 29399
• Product Classification: Bed, Ac-Powered Adjustable Hospital - Product Code FNL
• Product: Hill-Rom brand TotalCare Bed System; Model P1900.
• Code Information: All beds built during April and May of 2004.
• FEI Number: 1824206
• Recalling Firm/ Manufacturer: Hill-Rom, Inc.; 125 E Pearl St; Batesville IN 47006
• For Additional Information Contact: 800-445-3720
• Manufacturer Reason for Recall: An incorrect warning label was placed on these beds. Warning should say, "do not use for life sustaining equipment....."
• FDA Determined Cause: Other
• Action: Letters dated June 28, 2004 were sent to each consignee informing them of the problem and that Hill-Rom will inspect and verify the correct warning label is present.
• Quantity in Commerce: 180
• Distribution: Nationwide 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.