Class 2 Device Recall Alphenix, INFX8000V/B, INFX8000V/S, V9.5, Alphenix, INFX8000C/B, INFX8000C/S, V9.2

• Date Initiated by Firm: September 02, 2025
• Date Posted: October 08, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0037-2026
• Recall Event ID: 97589
• 510(K)Number: K210900 K233107
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: 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.
• Code Information: Serial Numbers: SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004.
• Recalling Firm/ Manufacturer: Canon Medical System, USA, INC.; 2441 Michelle Dr; Tustin CA 92780-7047
• For Additional Information Contact: 714-730-5000
• Manufacturer Reason for Recall: It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: Letters prepared and emailed to notify the customer of the defect. The letter contains a return reply form that is to be completed by the customer and emailed to CMSU for retention.
• Quantity in Commerce: 8
• Distribution: U.S.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB