# FDA recall Z-0037-2026

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2025-09-02.

## 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 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.

## Distribution

U.S.

## Key facts

- **Recall number:** Z-0037-2026
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-02
- **Report date:** 2025-10-15

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0037-2026

## Citation

> AI Analytics. FDA recall Z-0037-2026. Retrieved 2026-08-22 from https://api.ai-analytics.org/recall/Z-0037-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*