ClearanceBrief
Recall Z-0546-04 ยท LNH System, Nuclear Magnetic Resonance Imaging

Toshiba American Med Sys Inc

Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.

DateJul 20, 2004 (initiated Jan 27, 2004)
StatusTerminated
ReasonSoftware anomally causes image slices to be in incorrect order.
Root causeOther
ActionFirm sent letters to customers 1/28/2004 which explains how to avoid the adverse event and announces that a software fix is going to be made available.
Quantity24
DistributionNV, CO, OH, PA, CA, TN, FL, TX, OK, OR, NY, NJ and Puerto Rico.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K933018MRT-50GP
Toshiba America Mri, Inc., Feb 18, 1994
K961092VISART
Toshiba America Medical Systems, In.C, Jun 14, 1996
K990620EXCELART
Toshiba America Mri, Inc., May 14, 1999