Canon Aquilion One Vision CT Scanner Recalled for Data Loss Risk
Canon Medical System is recalling one Aquilion One Vision CT scanner because a software error can interrupt scans 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. The hazard involves data loss and operational interruption rather than direct physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Canon Medical System, USA, INC. is recalling one unit of the Canon Aquilion One Vision, Model TSX-301C, Whole-Body X-Ray CT Scanner. The recall is limited to the device with serial number 3DC18Y2118.
The recall is due to a software error that can occur during the execution of the eXam Plan. This error may interrupt the scanning process and prevent the system from shutting down normally, requiring the power to be forcibly turned off and the system rebooted. As a result, the acquired raw data may be lost.
The device was distributed to facilities in Alaska, Arkansas, California, Florida, Iowa, Idaho, Illinois, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Washington, Wisconsin, and West Virginia. Distribution included government and military facilities, but no foreign distribution occurred. Users should contact Canon Medical System for further instructions regarding the software issue.
The recalled product
- Product
- Canon Aquilion One Vision, Model TSX-301C
- 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 (3)
- Canon Aquilion ONE
- Whole-Body X-Ray CT Scanner
- Model TSX-301C - Serial number 3DC18Y2118.
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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