Class 2 Device Recall Advanta bed

• Date Initiated by Firm: March 08, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on September 02, 2004
• Recall Number: Z-0726-04
• Recall Event ID: 28420
• Product Classification: Bed, Ac-Powered Adjustable Hospital - Product Code FNL
• Product: Hill Rom brand Advanta bed; model P1600.
• Code Information: All units distributed between January 1, 2004 and February 11, 2004.
• FEI Number: 1824206
• 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: A potential pinch/shear point exists between the restraint strap hook located underneath the knee section and the foot rail mounting of the bed.
• FDA Determined Cause: Other
• Action: A recall letter dated March 8, 2004 was sent to each consignee advising them of the problem, and that Hill-Rom will visit the facility to modify the beds.
• Quantity in Commerce: 294
• Distribution: California, Delaware, Idaho, Indiana, Massachusetts, Michigan, Mississippi, New York, North Carolina, Ohio, South Dakota, Tennesee 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.