Canon Aquilion One CT Scanner Recalled for Scanning Interruption Errors
Canon Medical System is recalling two Aquilion One CT scanners because scanning errors may interrupt exams and force system reboots, resulting in the loss of acquired raw data.
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 harm to patients, and no injuries or illnesses are reported, fitting the criteria for a moderate severity recall.
Plain-English summary
Canon Medical System, USA, INC. is recalling two units of the Canon Aquilion One, Model TSX-301A, Whole-Body X-Ray CT Scanner. The recall involves serial numbers 7CA1892001 and 7CA1892002. These devices were distributed to facilities in 28 states, including government and military facilities, but were not distributed outside the United States.
The recall is being issued because scanning may be interrupted due to an error during the execution of the eXam Plan. When this error occurs, the system is unable to be shut down normally, requiring the power to be forcibly turned off and the system rebooted. This process results in the loss of the acquired raw data.
The source text does not specify the corrective action or the specific steps consumers or facility operators should take to resolve the issue. No injuries, illnesses, or deaths are reported in the source text.
The recalled product
- Product
- Canon Aquilion One, Model TSX-301A
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — CT Scanner
- Affected units
- 2
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 (2)
- Canon Aquilion ONE Whole-Body X-Ray CT Scanner
- TSX-301A - Serial number 7CA1892001and 7CA1892002.
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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