Canon Aquilion Lightning CT Scanner Recalled for System Shutdown Errors
Canon Medical System is recalling six Aquilion Lightning CT scanners because a software error can interrupt scanning and prevent normal shutdown, causing 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, but the hazard is limited to data loss and operational interruption without reports of patient injury or serious adverse health consequences, fitting the Moderate category for low-risk operational defects.
Plain-English summary
Canon Medical System, USA, INC. is recalling six units of the Canon Aquilion Lightning, Model TSX-036A, CT scanner. 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 being shut down normally, requiring the user to forcibly turn off the power and reboot the system.
The primary consequence of this defect is the loss of acquired raw data. The recall covers six specific devices with serial numbers 4LC1892122, 4LC1892125, 4LC1892129, 4LC1882114, 4OC1912163, and 4OC18Y2149. These 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. The distribution included government and military facilities, but no foreign distribution occurred.
Facilities with these devices should contact Canon Medical System for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Canon Aquilion Lightning, Model TSX-036A
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — CT Scanner
- Affected units
- 6
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 (7)
- Canon Aquilion Lightning
- TSX-036A - Serial numbers 4LC1892122
- 4LC1892125
- 4LC1892129
- 4LC1882114
- 4OC1912163
- and 4OC18Y2149.
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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