Agency classClass IIOur severity:High FDA (Devices)·Z-0198-2013·Announced 2012-11-28

GE Healthcare Recalls Mobile Radiographic Imaging Systems Due to Firmware Issue

GE Healthcare is recalling specific mobile radiographic imaging systems due to a firmware issue affecting technique accuracy as mandated by regulations.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any injuries or illnesses, and the hazard is a firmware issue affecting technique accuracy, which fits the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling specific mobile general purpose radiographic imaging systems, including the Optima XR 220amx, Brivo XR285amx, Optima XR200amx, and Optima XR200amx with Digital Upgrade. The recall involves 364 total units installed in the United States, distributed nationwide. The affected units are identified by part numbers 5555000-5 and 5555000-6.

The recall was initiated because GE Healthcare became aware of a firmware issue related to Technique Accuracy. This issue is relevant to standards mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

Healthcare facilities and consumers with these specific devices should contact GE Healthcare for instructions on how to resolve the firmware issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product: GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Radiographic Imaging
Hazard: firmware-defect
inaccurate-imaging
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: 5555000-5
5555000-6

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 →

Same manufacturer · GE Healthcare, LLC

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Same hazard · firmware defect