Canon CT Scanner Recall for Software Issue Causing Scan Failures
Canon Medical System is recalling 60 Aquilion Prime SP CT scanners due to a software defect that may prevent automatic scans, requiring rescans and contrast reinjection.
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 a software defect leading to procedural inefficiency and potential reinjection of contrast, which is a low-risk contamination or minor procedural issue without reported serious injuries or deaths.
Plain-English summary
Canon Medical System, USA, INC. is recalling 60 units of the Canon Aquilion Prime SP, Multislice Helical CT Scanner, model TSX-303B/8L. The recall is due to a software problem that could prevent the scanner from proceeding to the next scan automatically, even when specified. This failure may result in the need to rescan patients and reinject contrast medium.
The affected units were distributed nationwide in the United States. Specific serial numbers for the 60 units are listed in the official recall documentation. The product is intended to acquire and display cross-sectional volumes of the whole body, including the head.
Healthcare facilities should contact Canon Medical System for instructions on how to resolve the software issue. Patients who have undergone scans on these devices should consult their healthcare provider if they have concerns regarding the procedure or contrast medium administration.
The recalled product
- Product
- Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 60
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 (20)
- Serial Numbers: 8LA2052063
- 8LA19Z2034
- 8LA19X2004
- 8LA19Z2027
- 8LA19Z2029
- 8LA2052062
- 8LA2042055
- 8LA19Z2032
- 8OA2052059
- 8LA2042051
- 8LA2032044
- 8LA19X2002
- 1LB1922175
- 8LA2042050
- 8LA19X2007
- 8LA2012037
- 8LA19Y2021
- 8LA19Y2014
- 8LA2042056
- 8LA19Z2023
Distribution
Distributed nationwide across the United States.
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