GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Recall for Accuracy Deviation
GE OEC Medical Systems is recalling 61 mobile C-Arm X-ray units because the accuracy of the x-ray tube potential and current may exceed the manufacturer's specified limits.
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, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 61 units of the GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product installed in the United States. The recall is due to a deviation in the accuracy of the x-ray tube potential and current, which may exceed the design and labeling specification of +10%.
The affected devices are used for general surgical applications and musculoskeletal procedures to visualize. The recall is based on the requirement that the deviation of x-ray tube potential and current from indicated values shall not exceed the maximum deviation stated by the manufacturer.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with the defect.
The recalled product
- Product
- GE OEC Brivo 715 Prime 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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