GE Healthcare Recalls Optima Mobile X-ray Systems Due to Software Issue
GE Healthcare is recalling Optima XR200 and XR220 mobile X-ray systems because a software issue affects the visual indication required 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 2/5 (Moderate).
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, but the source text describes a software compliance issue regarding visual indications without reporting any injuries, illnesses, or specific safety hazards like fire or shock. This aligns with the rubric for moderate severity involving labeling or compliance errors without reported harm.
Plain-English summary
GE Healthcare, LLC is recalling the Optima Mobile X-ray System, specifically the Optima XR200 and Optima XR220 models. The recall involves 254 units that have been shipped to and installed in the United States.
The recall is due to a software issue on the interface of these mobile radiographic products. The issue relates to the visual indication mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3 standards.
Healthcare facilities and users of these specific X-ray systems should contact GE Healthcare for further instructions on how to resolve the software issue.
The recalled product
- Product
- GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 254
Distribution
Distributed nationwide across the United States.
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