The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
FDA Recall Z-2194-2010 · Posted 2010-08-10
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Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeKPR
Date Initiated2008-07-09
Date Terminated2010-10-27
Product Quantity7
Reason for Recall
Potential for bright artifacts to appear on the patient image from a previous exposure.
Firm 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 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.
Root Cause
Other
Distribution Pattern
Product was distributed in AZ, CA, FL and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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