CLASS II Device recall · Reported 6 Mar 2013 · FDA Enforcement Report

Philips DigitalDiagnost X-Ray System with Eleva recalled

Philips Healthcare is recalling Philips DigitalDiagnost X-Ray System with Eleva, distributed nationwide in the US. The recall was initiated on 25 Oct 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystems with Eleva SW version 2.1.3

Quantity recalled551

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-0884-2013
FDA event ID: 63674
Recalling firm: Philips Healthcare, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 25 Oct 2012
FDA classified: 26 Feb 2013
Reported: 6 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

25 Oct 2012	Recall initiated by company
26 Feb 2013	Classified by FDA	+124 days
6 Mar 2013	Published in enforcement report	+8 days

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

Reason for recall

When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.

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

Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system

Where it was distributed

Worldwide Distribution - USA Nationwide and the Foreign countries of: Austria, Canada, Belgium, China,Denmark, France, germany, Italy, Netherlands,New Zealand, Norway, Philippines, Portugual, SOuth Korea, Spain, Switzerland, Thailand, and UK.

Nationwide

Questions about this recall

Is Philips DigitalDiagnost X-Ray System with Eleva recalled?

Yes. Philips Healthcare recalled Philips DigitalDiagnost X-Ray System with Eleva on 25 Oct 2012. The recall is Class II and its status is Terminated. Recall number Z-0884-2013.

Why was it recalled?

Which lots are affected?

Systems with Eleva SW version 2.1.3

Where was it sold?

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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