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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 25, 2005
Date PostedJuly 13, 2005
Recall Status1 Terminated 3 on April 05, 2012
Recall NumberZ-0986-05
Recall Event ID 32570
510(K)NumberK002531 K961092 K990620 K993803 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
ProductMagnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart VANTAGE.
Code Information All.
Recalling Firm/
Manufacturer
Toshiba American Med Sys Inc
2441 Michelle Dr
Tustin CA 92781
For Additional Information ContactMichaela Mahl
714-730-5000
Manufacturer Reason
for Recall
Patient information A is displayed with images for patient B.
FDA Determined
Cause 2
Other
ActionFirm will have technicians correct each unit by visit. Instructions to them have issued.
Quantity in Commerce102
DistributionNationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LNH
510(K)s with Product Code = LNH
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