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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 Device Recall EXCELART Vantage, Atlas, and Titan MRl Systems MRT.1503 and MRT1504 see related information
Date Initiated by Firm May 13, 2008
Date Posted August 28, 2012
Recall Status1 Terminated 3 on September 04, 2012
Recall Number Z-2278-2012
Recall Event ID 62853
510(K)Number K063361  K080038  K032490  
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 CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 The status display in the sequence queue window may not change from "Current" to "Done".
FDA Determined
Cause 2		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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