FDAClass IIDecember 5, 2012

GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System recall: Software Issue

GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx…

Why was GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System recalled?

GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No - 5555000-6

Product
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx…
Recalling firm
GE Healthcare, LLC
Quantity
217 total Installed in the US
Distribution
Nationwide distribution
Recall date
December 5, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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