Drug recall
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
FDA recall event 64673 · Class II · Toshiba American Medical Systems Inc
Key facts
| Event ID | 64673 |
|---|---|
| Recall numbers | Z-1068-2013 |
| Recalling firm | Toshiba American Medical Systems Inc |
| Product type | Devices |
| Products | Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error… |
| Initiation date | Nov 14, 2012 |
| Report date | Apr 17, 2013 |
| Termination date | Apr 8, 2013 |
| 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: