Canon Medical recalls Alphenix INFX-8000C/F/V models due to potential loose fixing screws in ceiling suspension that could cause equipment failure during procedures.
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
✎ GovInfoNow plain-language explainer
Canon Medical is recalling Alphenix digital radiography systems (INFX-8000C, INFX-8000F, INFX-8000V) because screws in the ceiling suspension mechanism may become loose. This could lead to equipment failure during medical procedures if the system isn't properly secured. Read more at govinfonow.com/recall/697847-canon-alphenix-x-ray-systems-recall-loose-fixing-screws-risk.
“Canon Alphenix X-ray Systems Recall: Loose Fixing Screws Risk Equipment Failure.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697847-canon-alphenix-x-ray-systems-recall-loose-fixing-screws-risk. Based on FDA recall #Z-3014-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3014-2026%22&limit=1).
Canon Medical System, USA, INC. recalled Alphenix digital radiography/fluoroscopy systems due to loose fixing screws in the ceiling movement gear, according to the FDA on Aug. 4, 2026.
Model Number: INFX-8000C/B3, Serial Number: B3E2422005
Model Number: INFX-8000F/SG, Serial Number: SGC2412001
Model Number: INFX-8000V/SZ, Serial Number: SZA2422001
Model Number: INFX-8000V/SZ, Serial Number: SZA2432003
Model Number: INFX-8000V/SZ, Serial Number: SZA2442004
Model Number: INFX-8000V/SX, Serial Number: SXA2432001
Model Number: INFX-8000V/SX, Serial Number: SXA2432002
Model Number: INFX-8000V/B9, Serial Number: B9F2412001
Model Number: INFX-8000V/ST, Serial Number: STA2412001
The hazard
The fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose.
Context
GovInfoNow's records show Canon Medical System, USA, INC. has 26 other recalls on record since April 18, 2018. Other recent recalls of similar products include GE Optima XR240amx Mobile X-Ray System Recall (June 5, 2026), GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026), and GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026).
How to tell if you have this one
Check for Alphenix models INFX-8000C, INFX-8000F, or INFX-8000V with serial numbers listed in the recall notice. These systems are used in hospitals and clinics for medical imaging procedures.
Brand
Canon Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Equipment Stability
Inspect the ceiling suspension arm for loose fixing screws that could cause instability during use.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Georgia, Minnesota, Nevada, North Carolina, Ohio, Pennsylvania, Texas.
Recall timeline
FDA published this recall 29 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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-3014-2026 (August 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3014-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.