ClearanceBrief
Recall Z-0986-05 ยท LNH System, Nuclear Magnetic Resonance Imaging

Toshiba American Med Sys Inc

Magnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart VANTAGE.

DateJul 13, 2005 (initiated May 25, 2005)
StatusTerminated
ReasonPatient information A is displayed with images for patient B.
Root causeOther
ActionFirm will have technicians correct each unit by visit. Instructions to them have issued.
Quantity102
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K002531EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
Toshiba America Mri, Inc., Oct 26, 2000
K961092VISART
Toshiba America Medical Systems, In.C, Jun 14, 1996
K990620EXCELART
Toshiba America Mri, Inc., May 14, 1999
K993803EXCELART WITH PIANISSIMO
Toshiba America Mri, Inc., Feb 6, 2000