Recall Z-1655-2008 ยท FPO Stretcher, Wheeled
Hill-Rom, Inc.
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.
| Date | Sep 16, 2008 (initiated Apr 3, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 564 |
| Distribution | Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.