Class 2 Device Recall HillRom 100 Low Bed

• Date Initiated by Firm: April 08, 2008
• Date Posted: September 05, 2008
• Recall Status: Terminated 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.
• FEI Number: 1824206
• 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: 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.