Angiography systems recalled over collimator returning to default region of interest
Canon Medical Systems is recalling eight radiography/fluoroscopy systems because changing the acquisition program returns the collimator to a default ROI, leaving the X-ray area partially covered by a static image.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the X-ray field can be larger than the user has specified while partly hidden behind an overlay, and no injuries are reported.
Plain-English summary
A digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration, indicated for diagnostic and angiographic procedures on blood vessels in the heart, brain, abdomen and lower extremities, is being recalled for a software problem in the SPOT Fluoro program.
When SPOT Fluoro is first turned on, the default region of interest is selected, the collimator blades move to the boundary of that region, and a static image is overlaid around it, covering the collimated area. If the user changes the region of interest, the blades and static image adjust accordingly. However, when the acquisition program is changed, the collimator returns to the default region of interest position, which may be larger than the specified one, leaving the X-ray area partially covered by the static image. The problem will not occur if the function is not used.
The recall covers eight units, with serial numbers including SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002 and SZA2442004, distributed in the United States. The FDA has classified the action as Class II.
Sites operating affected serial numbers should follow Canon's instructions for the SPOT Fluoro function.
The recalled product
- Product
- This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 8
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 (8)
- Serial Numbers: SZA2422001
- SXA2432001
- SUC23Z2014
- BBF2392003
- SUC2392013
- SZA2422002
- SXA2432002
- SZA2442004.
Distribution
Distribution scope not specified by the agency.
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 →- SevereMedtronic MiniMed Go App Recall for Insulin Dose Reminder Failure
FDA (Devices) · 2026-10-28
- SeverePhilips Lumify Diagnostic Ultrasound System Recalled for Connection Issues
FDA (Devices) · 2026-10-28
- ModerateIntelerad IntelePACS Software Recalled for Image Display Mismatch
FDA (Devices) · 2026-10-21
- 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
Similar recalls
- HighCanon Medical System Recalls Infinix-8000F Fluoroscopy Systems Due to Loose Bolts
FDA (Devices) · 2020-06-17
- SevereCanon Medical System Recalls 24 Infinix-8000C Digital Radiography Systems
FDA (Devices) · 2020-06-17
- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- HighCanon Flat Panel Monitor Recall Due to Cable Breakage Risk
FDA (Devices) · 2020-12-09
- ModerateShimadzu FLUOROspeed X-ray System Software Recall for Image Display Failure
FDA (Devices) · 2024-11-13
- ModerateShimadzu BRANSIST safire Digital Angiography System Software Recall
FDA (Devices) · 2019-03-06