Recall Z-0270-05 ยท LNH System, Nuclear Magnetic Resonance Imaging
Toshiba American Med Sys Inc
Magnetic Resonance Imaging Systems under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN Excelart VANTAGE
| Date | Dec 2, 2004 (initiated Oct 6, 2004) |
| Status | Terminated |
| Reason | Software defect causes images to be rotated 180 degrees. |
| Root cause | Other |
| Action | Firm sent a letter to consignees October 6, 2004 describing the observed conditions causing the flaw to manifest itself. A workaround solution is also described in the letter. A software correction is under development and will be installed by a TAMS representative in the future. |
| Quantity | 67 |
| 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 |
| K023511 | EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2 Toshiba America Medical Systems, In.C, Nov 5, 2002 |
| 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 |