Toshiba CT System Recalled Due to X-Ray Generator Failure
Toshiba is recalling eight Aquilion One CT systems because high-voltage generator parts may fail, preventing X-ray exposure.
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 functional failure preventing X-ray exposure rather than a hazard causing injury or death, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Toshiba America Medical Systems, Inc. is recalling eight units of the TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. The recall was initiated due to the failure of parts used in the X-ray high-voltage generator.
In some cases, this failure means that X-ray exposure cannot be performed. The affected units were distributed in the United States, including the states of Maryland, West Virginia, Ohio, California, Minnesota, Indiana, New York, and Wisconsin.
Healthcare facilities should contact Toshiba America Medical Systems, Inc. for further instructions regarding the repair or replacement of the affected equipment.
The recalled product
- Product
- TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
- Manufacturer
- Toshiba American Medical Systems Inc
- Hazard
- Affected units
- 8
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 (10)
- SERIAL NO.: 1CB1262006
- 1DB1312033
- 1DC1352070
- 1DB1342060
- 1DB1332049
- 1DC1382081
- 1DB1312027
- 1DB1332045
- 1DC1362073
- 1CB12X2018.
Distribution
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