Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Reported: February 4, 2026 Initiated: December 19, 2025 #Z-1177-2026
Product Description
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Reason for Recall
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
Details
- Recalling Firm
- Canon Medical System, USA, INC.
- Units Affected
- 98 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Dominican Republic.
- Location
- Tustin, CA
Frequently Asked Questions
What product was recalled? ▼
Alphenix INFX-8000F, interventional fluoroscopic x-ray system. Recalled by Canon Medical System, USA, INC.. Units affected: 98 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 4, 2026. Severity: Moderate. Recall number: Z-1177-2026.
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