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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 62853
Product Type Devices
Status Completed
Recalling Firm Toshiba American Medical Systems Inc
City Tustin
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-05-13
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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 Class II The status display in the sequence queue window may not change from "Current" to "Done". 54 Z-2278-2012