Z-0623-2009

Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher Used...

Name: Z-0623-2009 Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher Used...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-12-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-12-30 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher Used for general R/F, fluoroscopy, radiography, and... on 2008-12-30. The reason FDA records is "System fails to meet requirements when it is used at kV levels greater than 115 kV at certain frame rates and in certain acquisition modes, as grid switch leakage may occur". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0623-2009
Status: Terminated
Initiated: 2008-12-30
Posted: 2009-09-25
Terminated: 2010-09-28
Recalling firm: Philips North America LLC
Product: Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher Used for general R/F, fluoroscopy, radiography, and angiography examinations.
Product code: KPR System, X-Ray, Stationary
Reason for recall: System fails to meet requirements when it is used at kV levels greater than 115 kV at certain frame rates and in certain acquisition modes, as grid switch leakage may occur.
FDA root cause: Radiation Control for Health and Safety Act
Action: A Customer Notification letter describing the failure, the means, by which a customer can prevent the failure mode from occurring, and actions planned by Philips to correct the problem were sent to all users of the affected systems. Philips will modify the system software and will be installed at no cost to the customer.
Quantity in commerce: 30 systems
Distribution: Nationwide distribution including states CA, CO, IA, ID, KS, MN, NC, NJ, NY, OH, SC, TX, UT, VA, and WI.
Product codes and lots: software version 4.3.1 or higher. Units are identified with Site Numbers: 538440, 542581, 543228, 543846, 543886, 544123, 544124, 544904, 545113, 545114, 548112, 551714, 553435, 553838, 554283, 554284, 554633, 554640, 556369, 557258, 41445127, 41445131, 41445800, 41455927, 41643223, 41849575, 42549980, 42799914, and 41445927.

Product code KPR

K050151Class IIMultidiagnost ElevaPhilips Medical Systems North America, Inc. / cleared 2005-02-09

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)