ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C recall (Canon Medical System, USA, INC.)
Medical deviceClass IIOngoing
Summary: Canon Medical System, USA, INC. is recalling ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C. Reason: Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
What is being recalled
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C
Why
Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, LA, MA, MI, MN, MS, NC, NV, OH, OR, TX. (states named: Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nevada, Ohio, Oregon, Texas)
How to tell if yours is affected
DI-04987670100192
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0289-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | October 12, 2026 |
| Reported | November 4, 2026 |
| Company | Canon Medical System, USA, INC. |
| Company location | Tustin, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 15 SYSTEMS |
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