Toshiba Aquilion LB CT Scanner Recalled for Reconstruction Error
Toshiba is recalling 165 Aquilion LB CT scanners because a reconstruction error may interrupt scanning if the range exceeds the maximum field of view.
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 involves a system interruption and reboot requirement rather than a direct physical injury or death, and the source explicitly states the issue has not occurred in the U.S., fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Toshiba America Medical Systems, Inc. is recalling 165 units of the Aquilion LB TSX-201A/2, 3 CT Scanner. The recall covers units distributed to 38 states across the United States.
The recall was initiated because a reconstruction operation error may occur if the scan range extends beyond the maximum Field of View (FOV). This error can interrupt scanning and may require the system to be rebooted. The source text notes that this specific issue has not occurred in the U.S.
Healthcare facilities using these scanners should contact Toshiba for further instructions on how to address the potential software error.
The recalled product
- Product
- Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 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)
- XL 700
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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