Drug recall
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
FDA recall event 66725 · Class II · Toshiba American Medical Systems Inc
Key facts
| Event ID | 66725 |
|---|---|
| Recall numbers | Z-0201-2014 |
| Recalling firm | Toshiba American Medical Systems Inc |
| Product type | Devices |
| Products | Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination… |
| Initiation date | Oct 28, 2013 |
| Report date | Nov 20, 2013 |
| Termination date | Dec 24, 2014 |
| 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: