Class II — Canon Medical System, USA, INC.
| Recalling firm | Canon Medical System, USA, INC. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities. |
| Quantity | 10 systems |
| Distribution | U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX. |
| Initiated | 2026-08-04 |
| Classified | 2026-08-25 |
| Recall number | Z-3014-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Canon Medical System, USA, INC. (Z-3014-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99222/
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