Shimadzu X-ray TV System Recalled for Oil Leak Risk
Shimadzu Medical Systems is recalling 39 SONIALVISION G4 X-ray TV Systems due to a potential oil leak from the x-ray tube housing.
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 injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Shimadzu Medical Systems is recalling 39 units of the Shimadzu X-ray TV System, Catalog No. SONIALVISION G4. The recall is being conducted because of the possibility of oil leaking from the x-ray tube housing under certain conditions.
The affected units are distributed across 21 states in the United States, including Texas, New York, South Dakota, Pennsylvania, Maryland, Ohio, Iowa, Indiana, Montana, Illinois, Florida, South Carolina, Oregon, California, Arkansas, Georgia, Connecticut, Nevada, Nebraska, and Washington. Specific serial numbers for the affected units are listed in the official recall documentation.
Consumers and healthcare facilities should contact Shimadzu Medical Systems for further instructions on how to address the potential oil leak issue.
The recalled product
- Product
- Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
- Manufacturer
- Shimadzu Medical Systems
- Hazard
- Affected units
- 39
Distribution
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