EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
FDA Recall Z-2278-2012 · Posted 2012-08-28
Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2008-05-13
Date Terminated2012-09-04
Product Quantity54
Reason for Recall
The status display in the sequence queue window may not change from "Current" to "Done".
Firm Action
A recall notification letter titled: "URGENT: MEDICAL DEVICE CORRECTION," was sent to customers. The letter stated the problem, corrective action, and (instructions) request to customers. Customers were instructed to perform the temporary recovery procedures if the problem occurs. Additionally, the acknowledgement sheet should be completed and faxed back. The information should be shared with all users, including the bio-medical or clinical engineering departments. Questions pertaining to the information for this recall were to be directed to (800) 421-1968.
Root Cause
Process design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K080038VANTAGE TITAN, MODEL MRT-1504/S3Toshiba America Medical Systems, In.C · 2008-01-22K063361EXCELART VANTAGE ATLAS, MODEL MRT-1503Toshiba America Medical Systems, In.C · 2006-11-21K032490TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2Toshiba America Medical Systems, In.C · 2003-08-21
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.