FDA recall, , Moderate risk
Canon Alphenix Angiography Systems
Alphenix X-ray systems may have loose fixing screws in the ceiling movement gear.
Summary by Recall Canary from the FDA notice
What happened
Canon Medical System, USA, INC., of Tustin, California, is recalling Alphenix Models INFX-8000C, INFX-8000F, and INFX-8000V, digital radiography/fluoroscopy systems used in diagnostic and interventional angiography procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
The recall is due to the fixing screws of the ceiling movement gear in the ceiling suspended arm, which are part of the X-ray interventional systems, and may become loose. The recall began on August 4, 2026, and was added to the FDA's Enforcement Report on August 25, 2026.
The systems were distributed nationwide in the states of California, Georgia, Minnesota, North Carolina, Nevada, Ohio, Pennsylvania, and Texas. The recall involves 10 systems.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device
- UDI-DI
- 30101165
- 30093711
- 30029686
- 79000002
- 30049491
- 30100053
- 30059175
- 30059180
- 30095017
- 30097052
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of California, Georgia, Minnesota, North Carolina, Nevada, Pennsylvania, Ohio, and Texas.
- Company
- Canon Medical System, USA, INC.Tustin, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99222
- Recall number
- Z-3014-2026
- Quantity recalled
- 10 systems
All recalls from Canon Medical System, USA, INC.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
