Canon Aquilion Precision CT Scanner Recalled for Data Loss Risk
Canon Medical System is recalling one Aquilion Precision CT scanner because a software error may interrupt scanning and cause loss of raw data.
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, but the hazard involves data loss and operational interruption rather than direct physical injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Canon Medical System, USA, INC. is recalling one unit of the Canon Aquilion Precision, Model TSX-304A, Whole-Body X-Ray CT Scanner. The recall involves a specific device with serial number 2DB1892018.
The recall is due to a software error that may occur during the execution of the eXam Plan. This error can interrupt the scanning process and prevent the system from shutting down normally, requiring a forced power-off and reboot. As a result, the acquired raw data may be lost.
The device was distributed to facilities in 28 states, including government and military facilities, but was not distributed outside the United States. There are no reports of patient injury or illness associated with this defect. Users should contact Canon Medical System for further instructions on how to address the software issue.
The recalled product
- Product
- Canon Aquilion Precision, Model TSX-304A
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — CT Scanner
- Hazard
- 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 (4)
- Canon Aquilion Precision
- Whole-Body X-Ray CT Scanner
- Model TSX-304A
- Serial number 2DB1892018.
Distribution
Part of a larger recall action
This product is one of 8 recalled by Canon Medical System, USA, 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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