Class 2 Device Recall VersaCare

• Date Initiated by Firm: December 29, 2004
• Date Posted: January 15, 2005
• Recall Status: Terminated on May 09, 2005
• Recall Number: Z-0402-05
• Recall Event ID: 30783
• Product Classification: Bed, Ac-Powered Adjustable Hospital - Product Code FNL
• Product: Hill-Rom brand VersaCare Bed; product P3200.
• Code Information: All serial numbers distributed prior to November 22, 2004.
• FEI Number: 1824206
• Recalling Firm/ Manufacturer: Hill-Rom, Inc.; 125 E Pearl St; Batesville IN 47006
• For Additional Information Contact: Tech Support; 800-445-3720
• Manufacturer Reason for Recall: A potential trip hazard exists when the fracture frame adaptor bracket is installed on the bed without the fracture frame.
• FDA Determined Cause: Other
• Action: Customers were notified via letter dated 12/29/04 and informed of the hazard. Hill-Rom will visit each account to place instruction labels on the beds.
• Quantity in Commerce: 324
• Distribution: Nationwide.
• 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.