Recall Z-0281-06 ยท LNH System, Nuclear Magnetic Resonance Imaging
Toshiba American Med Sys Inc
Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490
| Date | Dec 14, 2005 (initiated Oct 12, 2005) |
| Status | Terminated |
| Reason | To correct a hardware problem of water leakage in the cooling system inside the ASGC, leading to the replacement of the gradient coil. |
| Root cause | Other |
| Action | Toshiba America Medical Systems, Inc., (TAMS) customer service engineers will hand deliver The Advisory Letter and monitor the system during their monthly preventive maintenance. |
| Quantity | 65 |
| Distribution | Nationwide |
| 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 |