Recall Z-2278-2012 ยท LNH System, Nuclear Magnetic Resonance Imaging
Toshiba American Medical Systems Inc
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.
| Date | Aug 28, 2012 (initiated May 13, 2008) |
| Status | Terminated |
| Reason | The status display in the sequence queue window may not change from "Current" to "Done". |
| Root cause | Process design |
| Action | A recall notification letter titled: "URGENT: MEDICAL DEVICE CORRECTION," was sent to customers. The letter stated the problem, corrective action, and (instructions) request to customers. Customers were instructed to perform the temporary recovery procedures if the problem occurs. Additionally, the acknowledgement sheet should be completed and faxed back. The information should be shared with all users, including the bio-medical or clinical engineering departments. Questions pertaining to the information for this recall were to be directed to (800) 421-1968. |
| Quantity | 54 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032490 | TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2 Toshiba America Medical Systems, In.C, Aug 21, 2003 |
| K063361 | EXCELART VANTAGE ATLAS, MODEL MRT-1503 Toshiba America Medical Systems, In.C, Nov 21, 2006 |
| K080038 | VANTAGE TITAN, MODEL MRT-1504/S3 Toshiba America Medical Systems, In.C, Jan 22, 2008 |