Company:Toshiba American Medical Systems Inc.
Date of Enforcement Report 9/5/12
Class ll:
PRODUCT
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. Z-2278-2012
REASON
The status display in the sequence queue window may not change from “Current” to “Done”.
RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc.,Tustin, CA on 5/13/2008. Voluntary: Firm Initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
54
DISTRIBUTION
Nationwide
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