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Class 2 Device Recall EXCELART Vantage, Atlas, and Titan MRl Systems MRT.1503 and MRT1504 |
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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
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Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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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
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For Additional Information Contact |
714-730-5000
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Manufacturer Reason for Recall |
The status display in the sequence queue window may not change from "Current" to "Done".
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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
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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.
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510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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