Class 2 Device Recall

• Date Initiated by Firm: March 04, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 24, 2005
• Recall Number: Z-0810-04
• Recall Event ID: 28588
• Product Classification: Bed, Ac-Powered Adjustable Hospital - Product Code FNL
• Product: Magnum II Bariatric Patient Care System
• Code Information: Serial No. FTxxxxxx (where xxxxxx is a 6-digit number sequence)
• Recalling Firm/ Manufacturer: Hill-Rom Manufacturing, Inc.; 4349 Corporate Rd; Charleston SC 29405-7445
• For Additional Information Contact: Mark Lanning; 843-740-8586
• Manufacturer Reason for Recall: Bed may pose a health hazard due to: A) Inability to articulate the frame during transport, B) Exposed sharp edge of footplate, C) Shear point between seat section and lymph panel and D) Patient fall.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter via Federal Express on 3/9/2004.
• Quantity in Commerce: 1424 units
• Distribution: The Magnum II Bariatric Patient System is primarily leased by hospitals, although some units have been sold 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.