Toshiba Aquilion Lightning CT Scanner Recalled for Reconstruction Error
Toshiba is recalling 165 Aquilion Lightning CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum Field of View.
What this means for you
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 explicitly states the issue has not occurred in the U.S. and the hazard is a system interruption requiring a reboot, which fits the criteria for a moderate risk without reported injuries.
Plain-English summary
Toshiba America Medical Systems, Inc. is recalling 165 units of the Aquilion Lightning TSX-035A CT Scanner. The recall is due to a potential reconstruction operation error that may occur if the scan range extends beyond the maximum Field of View (FOV). This error can result in the interruption of scanning and may require the system to be rebooted.
The affected units were distributed to hospitals and medical facilities in the United States, including states such as Pennsylvania, Iowa, Massachusetts, South Dakota, Michigan, Louisiana, Kentucky, North Carolina, New York, Arkansas, Indiana, Wisconsin, Ohio, Florida, West Virginia, Washington, Connecticut, Mississippi, Alabama, North Dakota, Colorado, Hawaii, New Mexico, Minnesota, Idaho, Georgia, Montana, New Jersey, Nebraska, South Carolina, and Kansas.
Toshiba notes that this specific issue has not occurred in the U.S. Medical facilities using these scanners should contact Toshiba for instructions on how to address the potential error.
The recalled product
- Product
- Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
- Manufacturer
- Toshiba American Medical Systems Inc
- Category
- Medical Device — CT Scanner
- Affected units
- 165
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)
- LL 500
Distribution
Part of a larger recall action
This product is one of 4 recalled by Toshiba American Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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