The Recall Desk
ModerateFDA (Devices)·Z-0200-2013·Announced 2012-11-28

GE Healthcare Recalls Mobile Radiographic Imaging Systems Due to Firmware Issue

GE Healthcare is recalling Brivo XR 285 and Optima XR series 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. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a firmware issue affecting technique accuracy rather than a direct physical danger like fire or shock. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures without reported harm.

Plain-English summary

GE Healthcare, LLC is recalling specific mobile general purpose radiographic imaging systems, including the Brivo XR 285, Optima XR200amx, Optima XR220amx, and Optima XR200amx with Digital Upgrade. The recall involves 364 total units installed in the United States, distributed nationwide.

The recall was initiated because GE Healthcare became aware of a firmware issue related to Technique Accuracy. This issue is relevant to mandates under the US Code of Federal Regulations (21CFR) and IEC 60601-2-54. The affected units are identified by part numbers 5555000 and 5555000-2.

Healthcare facilities and consumers should contact GE Healthcare for further instructions on how to address the firmware issue. No specific injuries or illnesses have been reported in the source text.

The recalled product

Product
GE Healthcare Brivo XR 285 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 (2)

  • part numbers:5555000
  • 5555000-2

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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