Toshiba Aquilion 32/64 CT Systems Recalled for Software Display Error
Toshiba American Medical Systems is recalling 23 Aquilion 32/64 CT scanners due to a software issue that may cause incorrect Dose Length Product values to display.
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 hospitalizations or serious injuries are reported. The issue is a software display error rather than a direct physical hazard.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 23 units of the TSX-IOI: AQUILION 32/64 Computed Tomography (CT) systems. These devices are designed to produce cross-sectional images of a human body. The recall was initiated by the firm due to a potential software issue.
The specific defect involves the Dose Length Product (DLP) value, which may be displayed incorrectly when the vHP option is used. The affected units were distributed nationwide, including in Washington, Ohio, California, Texas, West Virginia, Illinois, Arizona, Wisconsin, Maine, North Carolina, Florida, Montana, and Hawaii.
Healthcare facilities should contact Toshiba American Medical Systems Inc to arrange for the necessary software correction or repair. Patients who have undergone scans on these devices should consult their healthcare provider if they have concerns regarding the reported software display issue.
The recalled product
- Product
- TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 23
Distribution
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