The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
Recall
- Recall Number
- Z-2194-2010
- Event Number
- 48998
- Firm
- Philips Medical Systems North America Co. Phillips
- FEI Number
- 1000524572
- Product Code
- KPR
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 9, 2008
- Posted
- August 10, 2010
- Terminated
- October 27, 2010
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431
Description
The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
Potential for bright artifacts to appear on the patient image from a previous exposure.
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 should not be too tight, such that the area of direct radiation is larger than 1.2 inch x 1.2 inch (or 30 mm x 30 mm). The minimum area is needed to detect and prevent memory artifacts. The firm will upgrade any affected products with the Field Change Order (FCO)70600031 and it will be implemented before the end of December 2008. The upgrade software is 1.0.3. The correction would be free of charge and the consignees should contact Philips Call Center at 800-772-9377, #5, #2.
Product was distributed in AZ, CA, FL and WA.
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