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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom TotalCare Bed

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 Class 2 Recall
HillRom TotalCare Bed
see related information
Date Posted May 01, 2009
Recall Status1 Terminated on October 13, 2010
Recall Number Z-1317-2009
Recall Event ID 51562
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Hill-Rom TotalCare Bed, Model P1900. The TotalCare (R) Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare (R) Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post
Code Information Serial numbers from J329AM1149 through J339AM1343.
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville, Indiana 47006
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
An e-ring may not have been installed during production, which could result in an inability to latch the siderail.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Consignees were notified by an Urgent Medical Device Correction letter dated 3/9/09 and were instructed that a Hill-Rom technician will visit each consignee to inspect and to correct the beds, if necessary. The firm asks that consignees locate and test their beds to make sure the siderails are latching correctly; forward a copy of the letter to users that were loaned or purchased the device and notify Hill-Rom of their new locations or owners; and if affected beds were disposed of or are no longer in use, to inform the firm of their serial numbers. If there are questions customers should contact their Hill-Rom Technical Support for their geographic region.
Quantity in Commerce 53 beds
Distribution Worldwide Distribution -- USA and Canada.
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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