Quick Facts at a Glance
- Recall Date
- September 2, 2025
- Hazard Level
- HIGH
- Brands
- Canon Medical System, Canon Medical System, USA
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Canon Medical System, Canon Medical System, USA
- Product type
- Digital radiography/fluoroscopy system
- Model numbers
- SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 2, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Canon Medical System, USA, INC. or your healthcare provider for instructions
About This Product
Digital radiography/fluoroscopy system used for diagnostic and interventional angiography to image blood vessels in heart, brain, abdomen and lower extremities.
Why This Is Dangerous
Software defect can cause default ROI misalignment, potentially exposing areas outside intended field or misreporting exposure area.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
High risk to patient exposure accuracy; facility downtime and service costs likely.
Practical Guidance
How to identify if yours is affected
- 1. Review model numbers against the recalled list.
- 2. Inspect SPOT Fluoro usage workflow settings.
- 3. Stop using device if in question.
Where to find product info
Model numbers on device label; recall notice with official list.
What timeline to expect
Remediation typically 4–8 weeks after verification.
If the manufacturer is unresponsive
- Escalate to hospital administration and formal recall channels.
- Document all interactions and request written remediation plan.
How to prevent similar issues
- Confirm SPOT Fluoro functionality is isolated from default ROI operations.
- Ensure software updates go through official channels only.
- Regularly review imaging QA processes and ROI settings.
Documentation advice
Keep model numbers, serial numbers, dates of service, and all recall communications.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers: SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004. Sold in the United States. Sold date and price not specified in provided data. Quantity: 8 units. Manufacturer: Canon Medical System, USA. Recall date: 2025-09-02. Status: ACTIVE.
Reported Incidents
No specific injuries or incidents are described in the provided data. Hazard is categorized as HIGH.
Key Facts
- 8 units recalled in the US
- Software defect in SPOT Fluoro protocol
- Default ROI causes partial coverage of X-ray area
- Acquisition program changes re-enable default ROI
- Manufacturer instructions to stop use and contact supplier
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.