Recall Z-0937-04 ยท LNH System, Nuclear Magnetic Resonance Imaging
Toshiba American Med Sys Inc
Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems.
| Date | Jul 20, 2004 (initiated May 6, 2004) |
| Status | Terminated |
| Reason | Software anomaly. |
| Root cause | Other |
| Action | Firm will send letters followed by visits to install software repair. |
| Quantity | 50 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002531 | EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 Toshiba America Mri, Inc., Oct 26, 2000 |
| K933018 | MRT-50GP Toshiba America Mri, Inc., Feb 18, 1994 |
| K961092 | VISART Toshiba America Medical Systems, In.C, Jun 14, 1996 |
| K990620 | EXCELART Toshiba America Mri, Inc., May 14, 1999 |
| K993803 | EXCELART WITH PIANISSIMO Toshiba America Mri, Inc., Feb 6, 2000 |