Official recall record
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-12-19
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Canon Medical System, USA, INC.
What the authority reported
It has been discovered that there is a possibility that 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. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-12-19 · US FDA — Medical Devices
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 - 2025-12-19 · US FDA — Medical Devices
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 - 2025-09-02 · US FDA — Medical Devices
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography c
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