The Recall Desk
ModerateFDA (Devices)·Z-0197-2013·Announced 2012-11-28

GE Healthcare Recalls Mobile Radiographic Systems Due to Firmware Issue

GE Healthcare is recalling specific mobile radiographic systems due to a firmware issue affecting technique accuracy.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

GE Healthcare, LLC is recalling the Optima XR 200amx with digital upgrade, along with the Brivo XR285amx, Optima XR200amx, and Optima XR22Oamx mobile radiographic systems. The recall is due to a discovered firmware issue that affects the technique accuracy of the devices. This issue is related to requirements mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.

The affected products are mobile general purpose radiographic imaging systems used for the human head and body. According to the source, 364 total units of the Optima XR 200amx with digital upgrade were installed in the US, with nationwide distribution. The specific part number associated with the recall is 5421698.

The source text does not provide specific instructions for consumers or healthcare providers on how to proceed, nor does it report any injuries or illnesses associated with this firmware issue.

The recalled product

Product
GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Radiographic Imaging
Hazard
Affected units
364

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • part number: 5421698

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · firmware defect

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