Recall Z-0061-05 ยท LNH System, Nuclear Magnetic Resonance Imaging
Toshiba American Med Sys Inc
Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System,
| Date | Nov 2, 2004 (initiated Sep 16, 2004) |
| Status | Terminated |
| Reason | Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly. |
| Root cause | Other |
| Action | Firm issued a letter to users on 9/29/2004 which includes a method to avoid the software problem until it can be corrected by an update. |
| Quantity | 22 |
| Distribution | PA, MD, FL, OH, NY, CA, AR, KY, OK, AZ, TX, NV, IN. |
| 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 |