Enforcement Report - Week of September 5, 2012
-
Back to Previous Page
Event Detail
| Event ID | 62853 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Toshiba American Medical Systems Inc |
| City | Tustin |
| State | CA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2008-05-13 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy. | Models MRT-1503 and MRT-1504 " MRT-1503 systems with software V9.01 *R240 through V9.20*R242 " MRT-1504 systems with software V9.21 *R24 | Class II | The status display in the sequence queue window may not change from "Current" to "Done". | 54 | Z-2278-2012 |
-
