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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 04, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 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 2		 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.
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