GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Recall for Accuracy Issues
GE OEC Medical Systems is recalling 61 mobile C-Arm X-ray units because their accuracy may exceed the design specification of +10%.
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, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 61 units of the GE OEC Brivo 865 Plus Mobile C-Arm X-Ray product installed in the United States. The product is used for general surgical applications and musculoskeletal procedures to visualize anatomy.
The recall is issued because the accuracy of the x-ray tube potential and current may exceed the design and labeling specification of +10%. This deviation is noted in relation to FDA regulations regarding the maximum deviation stated by the manufacturer.
The affected units are identified by specific serial numbers listed in the recall documentation. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 61
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by GE OEC Medical Systems, Inc 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.
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