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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 Device Recall HillRom 1000 Bed see related information
Date Initiated by Firm April 15, 2013
Date Posted June 05, 2013
Recall Status1 Terminated 3 on February 07, 2017
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 IN 47006-7520
For Additional Information Contact
812-934-7777
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		 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 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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