Drug recall
System INFX-8000C
FDA recall event 87419 · Class II · Canon Medical System, USA, INC.
Key facts
| Event ID | 87419 |
|---|---|
| Recall numbers | Z-1174-2021, Z-1175-2021, Z-1176-2021 |
| Recalling firm | Canon Medical System, USA, INC. |
| Product type | Devices |
| Products | System INFX-8000C, System INFX-8000F, System INFX-8000V |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. |
| Initiation date | Feb 5, 2021 |
| Report date | Mar 17, 2021 |
| 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: