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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom 1000 Bed

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 Class 2 Recall
HillRom 1000 Bed
see related information
Date Posted June 05, 2013
Recall Status1 Open
Recall Number Z-1466-2013
Recall Event ID 65257
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital.
Code Information Product number (P1160) with Serial Numbers J143AP0937 thru O080AP5661.
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
1069 State Road 46 E
Batesville, Indiana 47006-7520
Manufacturer Reason
for Recall
Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action On 4/16/2013 an URGENT MEDICAL DEVICE CORRECTION notification letter was sent to all consignees. The firm plans a visit to all facilities to correct each bed. Call Hill-Rom Technical Support at 800-445-3720 if you have any questions.
Quantity in Commerce 8,737 devices
Distribution Worldwide distribution: US (Nationwide) and countries of: Argentina , Bahamas, Bahrain, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Ethiopia, France, Ghana, Guam, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, N. Mariana Islands, Pakistan, panama, Paraguay, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, United States, US Virgin Islands, Venezuela and Vietnam.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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