Drug recall
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography…
FDA recall event 97589 · Class II · Canon Medical System, USA, INC.
Key facts
| Event ID | 97589 |
|---|---|
| Recall numbers | Z-0037-2026 |
| Recalling firm | Canon Medical System, USA, INC. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| 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… |
| Initiation date | Sep 2, 2025 |
| Report date | Oct 15, 2025 |
| City | Tustin |
| State | CA |
| Country | United States |
| FEI number | 2020563 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: