Recall Z-0037-2026— Canon Medical System, USA, INC.
Class II · Ongoing
Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2025-09-02. It names 2 FDA 510(k) clearances: K233107, K210900. 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.. Reason: 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..
- Recalling firm
- Canon Medical System, USA, INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-02
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K233107 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
- K210900 — Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
K-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
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.