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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 Device Recall HillRom Stretcher; Model P8000F see related information
Date Initiated by Firm April 03, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on December 29, 2009
Recall Number Z-1655-2008
Recall Event ID 46858
Product Classification Wheeled stretcher - 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 IN 47006
For Additional Information Contact
800-445-3720
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		 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 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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