This device is a digital radiography/fluoroscopy system used in a… — Class II medical device recall Z-0037-2026
Ongoing recall by Canon Medical System, USA, INC., reported 2025-10-15. It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator bla
| Recall number | Z-0037-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2025-09-02 |
| Classified | 2025-10-08 |
| Reported by FDA | 2025-10-15 |
| Quantity | 8 |
| Reason classes | software |
| Serial numbers | BBF2392003, SUC2392013, SUC23Z2014, SXA2432001, SXA2432002, SZA2422001, SZA2422002, SZA2442004 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0037-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.