Z-0431-2014Class II

Easy Diagnost Eleva Universal Fluoroscopic applications

Name: Z-0431-2014 Easy Diagnost Eleva Universal Fluoroscopic applications
Creator: Philips Medical Systems, Inc.
Published: 2013-10-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-10-30 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of Easy Diagnost Eleva Universal Fluoroscopic applications on 2013-10-30. FDA classified it as Class II and gives the reason as "The delivered application software was an outdated version to the model of equipment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0431-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-30
Posted: 2013-12-02
Terminated: 2017-01-09
Recalling firm: Philips North America LLC
Product: Easy Diagnost Eleva Universal Fluoroscopic applications
Product code: KPR System, X-Ray, Stationary
Reason for recall: The delivered application software was an outdated version to the model of equipment.
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical Systems sent an Urgent - Field Safety Notice dated October 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusromers were informed that the delivered application software was an outdated version to the model of their expipment and that a Philips Field Engineer will be implementing an upgrade of the application software. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of its contents. Customers with questions were instructed to contact their Philips representataive: Technical Support Line 1-800-722-9377. For questions regarding this recall call 1-800-722-9377.
Quantity in commerce: 19 devices
Distribution: Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.
Product codes and lots: 706050, 706083, 706088

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0431-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0431-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-02

Product code KPR

K031535Class IIPhilips Easydiagnost ElevaPhilips Medical Systems North America Co. / cleared 2003-06-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)