Z-2194-2010

The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system

Name: Z-2194-2010 The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-07-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-07-09 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system on 2008-07-09. The reason FDA records is "Potential for bright artifacts to appear on the patient image from a previous exposure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2194-2010
Status: Terminated
Initiated: 2008-07-09
Posted: 2010-08-10
Terminated: 2010-10-27
Recalling firm: Philips North America LLC
Product: The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Potential for bright artifacts to appear on the patient image from a previous exposure.
FDA 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 in commerce: 7
Distribution: Product was distributed in AZ, CA, FL and WA.
Product codes and lots: Serial Numbers 353320, 362600, 362601, 364209, 364210, 375245 and 375850.

Product code KPR

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)