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U.S. Department of Health and Human Services

Class 3 Device Recall Toshiba

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  Class 3 Device Recall Toshiba see related information
Date Initiated by Firm January 14, 2003
Date Posted March 21, 2003
Recall Status1 Terminated 3 on June 17, 2005
Recall Number Z-0668-03
Recall Event ID 25604
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product X-ray, Computed Tomography, Model TSX101A
Code Information None.
Recalling Firm/
Manufacturer		 Toshiba American Med Sys Inc
2441 Michelle Dr
Tustin CA 92781
For Additional Information Contact Paul Biggins
714-730-5000
Manufacturer Reason
for Recall		 Misassembly can cause fire.
FDA Determined
Cause 2		 Other
Action Letters to consignees were sent 2/12 and 2/13/2003. The letters inform customers that Toshiba America Medical Systems would be making appointments to check and service their machine.
Quantity in Commerce 68
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.
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