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U.S. Department of Health and Human Services

Class 2 Device Recall Century Bed

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  Class 2 Device Recall Century Bed see related information
Date Initiated by Firm April 28, 2008
Date Posted August 27, 2008
Recall Status1 Terminated 3 on September 22, 2009
Recall Number Z-1777-2008
Recall Event ID 47819
Product Classification Bed, AC-powered - Adjustable Hospital - Product Code FNL
Product Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers P9964-11, P9964-12, P9964-13, P-9964-14, P9964-15, P9964-16, P9964-41 and/or P9964-42.
Code Information All MOD 376 HBSW Siderail Upgraded accessory kits shipped between 9/19/06 and 3/18/07. Accessory kits do not bear serial numbers.
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
125 E Pearl St
Batesville IN 47006
For Additional Information Contact
800-445-3720
Manufacturer Reason
for Recall		 A risk of entrapment will exist between the head and foot rails if installation instructions are followed.
FDA Determined
Cause 2		 Other
Action Hill-Rom issued an Urgent Medical Device Correction letter on 4/28/2008 notifying consignees that they will be visited by a qualified Hill-Rom service technician or designee and provide a revised copy of the instruction sheet. The technician will either assist the facility to ensure proper installation or verify by signature that the facility understands the issue and will verify their beds had the upgrade kits installed in such a way that an entrapment gap does not exist.
Quantity in Commerce 69
Distribution Class II Recall - Nationwide Distribution --- including states of Florida, Illinois, New Mexico, Texas and Virginia.
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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