Recall Z-1045-04 ยท LNH System, Nuclear Magnetic Resonance Imaging
Toshiba American Med Sys Inc
Magnetic Resonance Imaging System(s) Visart and Exelart P2/ Exelart P3/ Exelart SPIN and Exelart VANTAGE
| Date | Jul 20, 2004 (initiated Jun 7, 2004) |
| Status | Terminated |
| Reason | Wrong positioning may cause patient burns. |
| Root cause | Other |
| Action | An advisory letter will issue to all users May 26, 2004, with updated positioning information, and an employee will visit to make sure the letter was received and understood. |
| Quantity | 58 |
| 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 |