FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
- Recall number
- Z-2194-2010
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
- Status
- Terminated
- Initiated
- 2008-07-09
- Posted
- 2010-08-10
- Terminated
- 2010-10-27
- 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 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.
- Quantity
- 7
- Distribution
- Product was distributed in AZ, CA, FL and WA.
- Lot, serial or model codes
- Serial Numbers 353320, 362600, 362601, 364209, 364210, 375245 and 375850.
- 510(k) numbers
- ["K031535","K063781"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28