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U.S. Department of Health and Human Services

Class 3 Device Recall HillRom Stretcher; Model P8000F

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 Class 3 Recall
HillRom Stretcher; Model P8000F
see related information
Date Posted September 16, 2008
Recall Status1 Terminated on December 29, 2009
Recall Number Z-1655-2008
Recall Event ID 46858
Product Classification Stretcher, Wheeled - Product Code FPO
Product Hill-Rom Procedural Stretcher with auto-contour option; Model P8000F. Wheeled hospital stretcher consisting of a platform mounted on a wheeled frame, designed to transport patients and to allow for patient care before, during and after transport.
Code Information All units with serial numbers H352AN3566 through I222AN9588 and shipped prior to 8/13/07.
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
125 E Pearl St
Batesville, Indiana 47006
Manufacturer Reason
for Recall
The auto contour function on/off handle may be inadvertently activated while the head of the stretcher is raised, increasing the possibility of the head section to become jammed and preventing it from lowering. This may result in a delay to the procedure.
FDA Determined
Cause 2
DESIGN: Device Design
Action Consignees will be visited to correct the problem and notified via a hand delivered Device Modification letter dated 4/3/08 at the time of the visit. If you have any questions please contact Jeffrey C. Shaul, Director, RA/QA Acute Care at (812) 931-2604.
Quantity in Commerce 564
Distribution Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland and United Kingdom.
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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