Canon Aquilion Premium CT Scanner Recalled for Data Loss Risk
Canon Medical System is recalling two Aquilion Premium CT scanners because a software error can interrupt scans and cause loss of 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 the loss of acquired raw data and system interruption, which is a functional defect without reported physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Canon Medical System, USA, INC. is recalling two units of the Canon Aquilion Premium, Model TSX-301B, whole-body X-ray CT scanner. The recall involves serial numbers 7CA18Y2002 and 7CA1892001.
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. As a result, the system power must be forcibly turned off and rebooted, which leads to the loss of the 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.
The recalled product
- Product
- Canon Aquilion Premium, Model TSX-301B
- 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 (3)
- Canon Aquilion Whole-Body X-Ray CT Scanner
- 160-detector row CT
- Model TSX-301B - Serial numbers 7CA18Y2002 and 7CA1892001.
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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