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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 August 24, 2004
Date Posted September 21, 2004
Recall Status1 Terminated 3 on January 31, 2005
Recall Number Z-1482-04
Recall Event ID 29897
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Hill-Rom brand VersaCare Bed; Model P3200.
Code Information All units.
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
125 E Pearl St
Batesville IN 47006
For Additional Information Contact Technical Support
800-445-3720
Manufacturer Reason
for Recall		 Pivot bolts on the sleep deck may become loose and fall out, allowing the head section to shift or to drop to one side, and a grounding warning label is missing.
FDA Determined
Cause 2		 Other
Action Recall letters dated August 24, 2004 were sent to consignees advising them to inspect and monitor the beds until Hill-Rom can visit and make corrections.
Quantity in Commerce 5048
Distribution Nationwide, Brazil, Canada, Hong Kong and United Arab Emirates.
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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