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U.S. Department of Health and Human Services

Class 2 Device Recall EXCELART Vantage, Atlas, and Titan MRl Systems MRT.1503 and MRT1504

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 Class 2 Recall
EXCELART Vantage, Atlas, and Titan MRl Systems MRT.1503 and MRT1504
see related information
Date Posted August 28, 2012
Recall Status1 Terminated on September 04, 2012
Recall Number Z-2278-2012
Recall Event ID 62853
Premarket Notification
510(K) Numbers
K032490  K063361  K080038 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
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.
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
Recalling Firm/
Manufacturer
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92780-7047
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The status display in the sequence queue window may not change from "Current" to "Done".
FDA Determined
Cause 2
DESIGN: Process Design
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.
Quantity in Commerce 54
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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