Recall Z-1655-2008
Hill-Rom, Inc. · initiated April 3, 2008
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.
Codes / lots: All units with serial numbers H352AN3566 through I222AN9588 and shipped prior to 8/13/07.
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: Device Design
Action taken
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.
Details
- Recall number
- Z-1655-2008
- Initiated
- April 3, 2008
- Posted by FDA
- September 16, 2008
- Terminated
- December 29, 2009
- Product code
- FPO – Stretcher, Wheeled
- Quantity
- 564
- Distribution
- Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland and United Kingdom.
- Recalling firm
- Hill-Rom, Inc., Batesville, IN