Philips Medical Systems North America Co. Phillips The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
Serial Numbers 353320, 362600, 362601, 364209, 364210, 375245 and 375850.
Products Sold
Serial Numbers 353320, 362600, 362601, 364209, 364210, 375245 and 375850.
Philips Medical Systems North America Co. Phillips is recalling The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system. due to Potential for bright artifacts to appear on the patient image from a previous exposure.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for bright artifacts to appear on the patient image from a previous exposure.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, IN, WA
Page updated: Jan 10, 2026