Recalls / —
—#72491
Product
The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
- FDA product code
- KPR — System, X-Ray, Stationary
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K031535, K063781
- Affected lot / code info
- Serial Numbers 353320, 362600, 362601, 364209, 364210, 375245 and 375850.
Why it was recalled
Potential for bright artifacts to appear on the patient image from a previous exposure.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Philips Medical Systems North America Co. Phillips
- Address
- 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431
Distribution
- Distribution pattern
- Product was distributed in AZ, CA, FL and WA.
Timeline
- Recall initiated
- 2008-07-09
- Posted by FDA
- 2010-08-10
- Terminated
- 2010-10-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #72491. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.