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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom 100 Low Bed

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  Class 2 Device Recall HillRom 100 Low Bed see related information
Date Initiated by Firm April 08, 2008
Date Posted September 05, 2008
Recall Status1 Terminated 3 on October 13, 2010
Recall Number Z-1603-2008
Recall Event ID 47469
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Hill-Rom 100 Low Bed; Model No. P3930.
Code Information All units.
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
125 E Pearl St
Batesville IN 47006
For Additional Information Contact
800-445-3720
Manufacturer Reason
for Recall		 The upper deck may collapse to its lowest position and the caster brakes may fracture if the bed is moved while the brakes are locked.
FDA Determined
Cause 2		 Device Design
Action Consignees were notified via letter dated April 8, 2008 to lower these beds to their lowest position, to remove the beds from use if they move more than 1/2 inch with the brakes locked and that the firm will repair these beds when fixes become available. If you have questions regarding this recall, contact Hill-Rom Technical Support at 800-445-3730.
Quantity in Commerce 753 beds
Distribution Worldwide: USA 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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