Recall Z-1176-2026— Canon Medical System, USA, INC.
Class II · Ongoing
Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2025-12-19. It names one FDA 510(k) clearance: K210900. Product: Alphenix INFX-8000C, interventional fluoroscopic x-ray system. Reason: 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.
- Recalling firm
- Canon Medical System, USA, INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-12-19
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Alphenix INFX-8000C, 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.