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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 25, 2005
Date Posted July 13, 2005
Recall Status1 Terminated 3 on April 05, 2012
Recall Number Z-0986-05
Recall Event ID 32570
510(K)Number K961092  k990620  k993803  k002531  k002531  
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Magnetic Resonance Imaging Systems;

Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart VANTAGE.
Code Information All.
Recalling Firm/
Toshiba American Med Sys Inc
2441 Michelle Dr
Tustin CA 92781
For Additional Information Contact Michaela Mahl
Manufacturer Reason
for Recall
Patient information A is displayed with images for patient B.
FDA Determined
Cause 2
Action Firm will have technicians correct each unit by visit. Instructions to them have issued.
Quantity in Commerce 102
Distribution Nationwide.
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.
510(K)s with Product Code = LNH and Original Applicant = TOSHIBA AMERICA MRI, INC.