Canon Aquilion Prime SP CT Scanner Recalled for Data Loss Risk
Canon Medical System is recalling 10 Aquilion Prime SP CT scanners because a software error may interrupt scanning 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 data loss and service interruption without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Canon Medical System, USA, INC. is recalling 10 units of the Canon Aquilion Prime SP, Model TSX-303B, multislice helical CT scanner. The recall involves specific serial numbers listed in the agency record. These devices were distributed to hospitals and facilities in 28 states, including government and military facilities, but were not distributed outside the United States.
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 may require a forced power-off and reboot, which leads to the loss of acquired raw data.
No injuries or illnesses have been reported in connection with this recall. The hazard is limited to the loss of data and interruption of service. Healthcare facilities should contact Canon Medical System for instructions on how to address the software issue and manage the affected devices.
The recalled product
- Product
- Canon Aquilion Prime SP, Model TSX-303B
- 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 (12)
- Canon Aquilion Prime SP
- Multislice Helical CT Scanner
- Model TSX-303B - Serial numbers 1LB1882092
- 1LB1882088
- 1LB18X2111
- 1LB1882086
- 1LB18X2129
- 1LB18X2109
- 1LB1882087
- 1LB1882090
- 1LB1892093
- and 1OB1892102.
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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