Eos Imaging Recalls EOS X-ray Systems Due to Generator Failures
Eos Imaging Inc is recalling 12 EOS X-ray systems in the US because the anode controller board can fail, causing generator issues.
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 agency classified this as a Class II recall. The source text describes equipment malfunction (generator failures) but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Eos Imaging Inc is recalling 12 EOS X-ray Medical Diagnostic systems installed in the United States. These systems are used for digital radiography in general radiographic examinations.
The recall was initiated after it was discovered that several units experienced generator failures. These failures were caused by the failure of the anode controller board, which is responsible for driving the rotation of the X-ray tube anode.
The recall covers all associated serial numbers for the affected systems. The distribution pattern is nationwide. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
- Manufacturer
- Eos Imaging Inc
- Category
- Medical Device — X-ray Equipment
- Hazard
- Affected units
- 12
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 (1)
- All associated Serial Numbers
Distribution
Distributed nationwide across the United States.
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