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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom Basic Care Bed

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  Class 2 Device Recall HillRom Basic Care Bed see related information
Date Initiated by Firm September 16, 2009
Date Posted August 03, 2010
Recall Status1 Terminated 3 on March 16, 2012
Recall Number Z-2169-2010
Recall Event ID 56018
Product Classification AC-Powered Adjustable Hospital Bed - Product Code FNL
Product Hill-Rom Basic Care Bed, P1440A (Electric), Hill Rom Batesville, IN.

Intended for low to moderate acuity patients in the low end acute care area of the hospital.
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Recalling Firm/
Manufacturer
Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006
For Additional Information Contact
812-934-7777
Manufacturer Reason
for Recall
The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the pivot pin E-ring, which could cause the E-ring to come off.
FDA Determined
Cause 2
Device Design
Action The firm sent an Urgent Field Safety Notice to its customers dated 9/16/2009. The letter identified the affected product, explained the reason for the recall, actions to be taken, and a contact reference. Customers are to locate the affected product, examine the pivot points and ensure the E-ring is present. If the E-ring is missing, then the affected bed is to be taken out of service. Customers' distributors or agents will contact them with a permanent fix. Questions should be directed towards Hill-Rom Technical Support.
Quantity in Commerce 4,535 beds
Distribution Worldwide Distribution -- Argentina, Bahrain, Bhutan, Brazil, Bulgaria, Chili, China, Columbia, Costa Rica, Ecuador, Egypt, Eritrea, France, Hong Kong, India, Indonesia, Iran, Iraq, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mexico, Morocco, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Syria, Taiwan, Thailand, Trinidad & Tobago, Turkey, United Arab Emirates, United States, Uruguay, 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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