This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuratio
FDA device recall Z-0037-2026 · posted 2025-10-08 · Open, Classified
Recall details
- Recalling firm
- Canon Medical System, USA, INC.
- 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.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 8
- Distribution
- U.S.
- Date initiated
- 2025-09-02
- Date posted
- 2025-10-08
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 (K233107) | Canon Medical Systems Corporation | 2024-08-30 |
| Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 (K210900) | Canon Medical Systems Corporation | 2021-04-12 |