Canon INFX-8000C X-ray System Recall: Image Shift Risk
Canon Medical recalls INFX-8000C X-ray systems with model CAS-880A/CAS-830B due to potential image shift at certain C-arm angles. Affected units may show inaccurate imaging.
Lower-risk recall
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Contact the company
What happened, in plain English
Canon Medical is recalling its INFX-8000C X-ray systems (models CAS-880A and CAS-830B) because the x-ray field might shift relative to the display screen at some angles. This could lead to inaccurate imaging during procedures. Read more at govinfonow.com/recall/63300-canon-infx-8000c-x-ray-system-recall-image-shift-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63300-canon-infx-8000c-x-ray-system-recall-image-shift-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1175-2021
Cite this page
“Canon INFX-8000C X-ray System Recall: Image Shift Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63300-canon-infx-8000c-x-ray-system-recall-image-shift-risk. Based on FDA recall #Z-1175-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1175-2021%22&limit=1).
Why it’s dangerous
The x-ray irradiation field can shift relative to the image display screen when the C-arm is positioned at certain angles. This shift might cause the system to show inaccurate images during medical procedures.
Who’s affected
Healthcare professionals using Canon's INFX-8000C X-ray systems with models CAS-880A or CAS-830B are most at risk. Patients receiving imaging during these procedures may also be affected.
How to tell if you have this one
Check for the model numbers CAS-880A or CAS-830B on the Canon INFX-8000C X-ray system. The recall applies to units sold in the U.S. by Canon Medical System, USA, INC.
- Brand
Canon Medical- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide
| Recall number | Product, codes & lots |
|---|---|
| Z-1174-2021 | System INFX-8000V; Model: CAS-880A, CAS-830B |
| Z-1175-2021 | System INFX-8000C; Model: CAS-880A, CAS-830B |
| Z-1176-2021 | System INFX-8000F; Model: CAS-880A, CAS-830B |
What to do — step by step
Check Model Number
Identify the model number on your system to confirm if it's CAS-880A or CAS-830B.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall dangerous?
The recall indicates a potential for inaccurate imaging during procedures, but the risk of serious injury is not described in the official notice.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1175-2021 (February 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1175-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.