Lower risk Medical device recall · FDA · Published January 31, 2022

Canon INFX-8000V Fluoroscopy Dose Rate Risk Recall

Canon recalls INFX-8000V fluoroscopy systems for potential dose rate exceedance during biplane procedures. Affected units include Alphenix i with software versions 8.0, 9.0, or 9.2 and TFP 1200C FPD. No remedy specified in recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1666-2022Medical device Canon Medical ›

Lower-risk recall

The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.

Take action

Contact the company

Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047

✎ GovInfoNow plain-language explainer

Canon is recalling its INFX-8000V medical imaging systems due to a potential risk of exceeding safe radiation dose rates during biplane fluoroscopy procedures. This could lead to unnecessary radiation exposure for patients or staff if the system is used without proper monitoring. Read more at govinfonow.com/recall/61202-canon-infx-8000v-fluoroscopy-dose-rate-risk-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/61202-canon-infx-8000v-fluoroscopy-dose-rate-risk-recall · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1666-2022

Cite this page

“Canon INFX-8000V Fluoroscopy Dose Rate Risk Recall.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/61202-canon-infx-8000v-fluoroscopy-dose-rate-risk-recall. Based on FDA recall #Z-1666-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1666-2022%22&limit=1).

The FDA announced on Jan. 31, 2022, that Canon Medical System USA Inc. is recalling INFX-8000V fluoroscopic systems because the dose rate might exceed conforming values during biplane fluoroscopy. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Canon Medical
Product: INFX-8000V
Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD
Quantity: 16 systems

The hazard

The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy, according to the FDA.

Context

GovInfoNow's records show Canon Medical System USA Inc. has had 27 other recalls since April 18, 2018. Other recent recalls of similar products include AGFA DR 800 X-Ray System Recall (Nov. 18, 2025), Siemens ARTIS pheno X-ray System Recalled (March 9, 2026), and Philips Brilliance CT 64 Medical Scanner Recall (Aug. 7, 2026).

How to tell if you have this one

Check if your system includes the Alphenix i software with versions 8.0, 9.0, or 9.2 and the TFP 1200C FPD. The INFX-8000V is used for radiographic and fluoroscopic medical imaging procedures.

Brand
Canon Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Details
Identify if your system has Alphenix i software versions 8.0, 9.0, or 9.2 and TFP 1200C FPD.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 7 months after the firm started it.

Jan 31, 2022Firm started the recall
Sep 1, 2022FDA classified it Class II
Sep 7, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Canon Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/61202-canon-infx-8000v-fluoroscopy-dose-rate-risk-recall">Canon INFX-8000V Fluoroscopy Dose Rate Risk Recall (GovInfoNow)</a>

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-1666-2022 (January 31, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1666-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.