CLASS II Device recall · Reported 11 Dec 2013 · FDA Enforcement Report

Easy Diagnost Eleva Universal Fluoroscopic applications recalled

Philips Medical Systems is recalling Easy Diagnost Eleva Universal Fluoroscopic applications, distributed nationwide in the US. The recall was initiated on 30 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes706050, 706083, 706088

Quantity recalled19 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0431-2014
FDA event ID: 66705
Recalling firm: Philips Medical Systems, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 30 Oct 2013
FDA classified: 2 Dec 2013
Reported: 11 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

30 Oct 2013	Recall initiated by company
2 Dec 2013	Classified by FDA	+33 days
11 Dec 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The delivered application software was an outdated version to the model of equipment.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Easy Diagnost Eleva Universal Fluoroscopic applications

Where it was distributed

Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.

Nationwide California Delaware Florida Massachusetts Minnesota New Hampshire Ohio Oregon South Carolina Texas Washington

Questions about this recall

Is Easy Diagnost Eleva Universal Fluoroscopic applications recalled?

Yes. Philips Medical Systems recalled Easy Diagnost Eleva Universal Fluoroscopic applications on 30 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-0431-2014.

Why was it recalled?

The delivered application software was an outdated version to the model of equipment.

Which lots are affected?

706050, 706083, 706088

Where was it sold?

Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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