Recall Z-2194-2010 ยท KPR System, X-Ray, Stationary
Philips Medical Systems North America Co. Phillips
The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
| Date | Aug 10, 2010 (initiated Jul 9, 2008) |
| Status | Terminated |
| Reason | Potential for bright artifacts to appear on the patient image from a previous exposure. |
| Root cause | Other |
| Action | On July 9, 2008, Philip Medical System began sending out the URGENT-Device Correction letter to their consignees. This letter describes the recalled product as EasyDiagnost Eleva with DRF system with SW release 1.0. The firm informs the consignees that under special circumstances there is a small possibility that bright artifacts appear on a patient image from a previous exposure. The consignees are advised to take care about the X-ray field limitation. If the detector is not affected by direct radiation, no problem will occur. If direct radiation reaches the detector, the collimation sh |
| Quantity | 7 |
| Distribution | Product was distributed in AZ, CA, FL and WA. |
| FDA record | Open on fda.gov |