Agency classClass IIOur severity:High FDA (Devices)·Z-0199-2013·Announced 2012-11-28

GE Healthcare Recalls Mobile Radiographic Units Due to Firmware Issue

GE Healthcare is recalling specific mobile radiographic units due to a firmware issue affecting technique accuracy as mandated by federal 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 and involves a technical defect (firmware issue) affecting technique accuracy in a medical device. While no injuries or illnesses are reported, the potential for diagnostic errors in a high-risk medical context aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling specific mobile radiographic imaging units, including the Brivo XR285amx, Optima XR200amx, Optima XR22Oamx, 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 5555000-3 and 5555000-4.

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 agency has classified this recall as Class II.

Healthcare facilities and consumers with these specific units should contact GE Healthcare for further instructions on resolving the firmware issue. No specific dates or additional distribution details are provided in the source text.

The recalled product

Product: GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Radiographic Imaging
Hazard: firmware-defect
technical-inaccuracy
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: 5555000-3
5555000-4

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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