EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Bo...
FDA Recall #Z-2278-2012 — Class II — May 13, 2008
Product Description
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.
Reason for Recall
The status display in the sequence queue window may not change from "Current" to "Done".
Recalling Firm
Toshiba American Medical Systems Inc — Tustin, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
54
Distribution
Nationwide Distribution
Code Information
Models MRT-1503 and MRT-1504 " MRT-1503 systems with software V9.01 *R240 through V9.20*R242 " MRT-1504 systems with software V9.21 *R24
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated