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
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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
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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 |
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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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