Toshiba CT Systems Recalled for X-Ray Output Software Defect
Toshiba is recalling 338 Aquilion CT systems because a software defect may prevent X-ray exposure from starting during contrast studies.
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 indicates a temporary or medically reversible adverse health consequence. The specific defect described is a failure to initiate X-ray exposure, which is a functional failure rather than a direct source of injury or contamination, fitting the Moderate category for low-risk functional defects without reported injuries.
Plain-English summary
Toshiba American Medical Systems Inc. is recalling 338 units of various Aquilion Computed Tomography (CT) X-Ray Systems, including the TSX-101A, TXS-101/R, TSX-301A, TSX-301B, and TSX-302A models. The affected devices were distributed nationwide.
The recall was initiated because Toshiba's investigation revealed a problem with the X-ray output control software. This defect may cause the X-ray output conditions to be set incorrectly, resulting in the X-ray exposure not starting under the scan conditions used for contrast studies.
Healthcare facilities and consumers with these specific serial numbers should contact Toshiba American Medical Systems Inc. for further instructions on how to resolve the software issue.
The recalled product
- Product
- TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography…
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 338
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 (20)
- SERIAL NUMBER JDA1062176
- JDA1062177
- JDA1072183
- JDA1072184
- JDA1072186
- JDA1072187
- JDA1082188
- JDA1082189
- JDA1082190
- JDA10X2191
- JDA10X2192
- JDA10X2193
- JDA10X2194
- JDA10X2195
- JDA10X2196
- JDA10X2197
- JDA10X2198
- JDA10Y2199
- JDA10Y2200
- JDA10Y2201
Distribution
Distributed nationwide across the United States.
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