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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
Related recalls
Same manufacturer · Canon Medical System, USA, INC.
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- ModerateAlphenix INFX-8000F systems recalled over ceiling suspension screws that loosen
FDA (Devices) · 2026-02-04
- ModerateAlphenix INFX-8000H systems recalled over ceiling suspension screws that loosen
FDA (Devices) · 2026-02-04
- HighQ.namix R fluoroscopy systems recalled over unflipped and mismatched images
FDA (Devices) · 2026-02-04
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateCanon Aquilion Prime SP CT Scanner Recalled for Data Loss Risk
FDA (Devices) · 2020-04-22
- ModerateCanon Aquilion Prime CT Scanner Recalled for System Shutdown Errors
FDA (Devices) · 2020-04-22
- ModerateCanon Aquilion Premium CT Scanner Recalled for Data Loss Risk
FDA (Devices) · 2020-04-22
- ModerateCanon Aquilion One CT Scanner Recall for System Interruption
FDA (Devices) · 2020-04-22
- HighCanon PET-CT Scanner Recalled for Software Malfunction Causing Scan Failures
FDA (Devices) · 2021-10-27
- ModerateCanon Aquilion Precision CT Scanner Recalled for Data Loss Risk
FDA (Devices) · 2020-04-22