Drug recall
MRI system: Vantage Elan, Model: MRT-2020
FDA recall event 93874 · Class II · Canon Medical System, USA, INC.
Key facts
| Event ID | 93874 |
|---|---|
| Recall numbers | Z-1248-2024, Z-1249-2024, Z-1250-2024 |
| Recalling firm | Canon Medical System, USA, INC. |
| Product type | Devices |
| Products | MRI system: Vantage Elan, Model: MRT-2020, MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550, Vantage Titan, Model: MRT-1504 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values… |
| Initiation date | Jan 29, 2024 |
| Report date | Mar 13, 2024 |
| 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: