Canon Aquilion Prime CT Scanner Recalled for System Shutdown Errors
Canon Medical System is recalling 10 Aquilion Prime CT scanners because a software error may interrupt scanning and prevent normal shutdown, resulting in data loss.
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. The hazard involves data loss and operational interruption rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving significant but non-life-threatening operational defects.
Plain-English summary
Canon Medical System, USA, INC. is recalling 10 units of the Canon Aquilion Prime, Model TSX-303A, CT scanners. The recall is due to a software error during the execution of the eXam Plan that may interrupt scanning. When this error occurs, the system is unable to be shut down normally, requiring a forced power-off and reboot, which results in the loss of acquired raw data.
The affected devices were 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.
Healthcare facilities should contact Canon Medical System for further instructions regarding the recall and potential software updates or repairs to address the shutdown issue.
The recalled product
- Product
- Canon Aquilion Prime, Model TSX-303A
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — CT Scanner
- Affected units
- 10
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 (11)
- Canon Aquilion PRIME
- TSX-303A - Serial numbers 1CB1892050
- FLC1882279
- FLC1892282
- FLC1882278
- FLC18Y2301
- FLC1892288
- FOC1892284
- FOC1872277
- FOC18X2289
- and FOC18Y2296.
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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