CLASS II Device recall · Reported 28 Nov 2012 · FDA Enforcement Report

Optima XR 200amx with digital upgrade Mobile general recalled

GE Healthcare is recalling GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic, distributed nationwide in the US. The recall was initiated on 20 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codespart number: 5421698

Quantity recalled364 total units installed in US

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-0197-2013
FDA event ID: 63597
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 20 Sep 2012
FDA classified: 16 Nov 2012
Reported: 28 Nov 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

20 Sep 2012	Recall initiated by company
16 Nov 2012	Classified by FDA	+57 days
28 Nov 2012	Published in enforcement report	+12 days

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

Reason for recall

It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.

Product as listed by the FDA

GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the recalled?

Yes. GE Healthcare recalled Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the on 20 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0197-2013.

Why was it recalled?

Which lots are affected?

part number: 5421698

Where was it sold?

Nationwide Distribution

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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