Toshiba CT System Recalled for Software Error in Low-Current Scans
Toshiba American Medical Systems Inc. is recalling one CT scanner in Maryland due to a software defect that may trigger false error messages during low-current scans.
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. The hazard is a software error that may cause false error processing, but the source explicitly states the x-ray output remains normal and no injuries are reported, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Toshiba American Medical Systems Inc. is recalling one unit of the Toshiba TSX-30IC AQUlLlON ONE System, a computed tomography (CT) X-ray system capable of whole-body scanning. The affected unit, identified by serial number 1CB1262006, was distributed in the state of Maryland.
The recall is due to a problem with the control software of the x-ray high-voltage generator. If a scan is performed with a tube current less than 30mA, the software may detect an error and perform error processing even though the x-ray output is normal. This issue does not indicate a failure of the x-ray output itself, but rather a software malfunction in error detection.
Healthcare facilities that possess this specific unit should contact Toshiba American Medical Systems Inc. for further instructions on how to address the software issue. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 1
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)
- Serial No: 1CB1262006
Distribution
Distributed in 1 state:
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