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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 Toshibasee related information
Date Initiated by FirmJanuary 14, 2003
Date PostedMarch 21, 2003
Recall Status1 Terminated 3 on June 17, 2005
Recall NumberZ-0668-03
Recall Event ID 25604
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
ProductX-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 ContactPaul Biggins
714-730-5000
Manufacturer Reason
for Recall		Misassembly can cause fire.
FDA Determined
Cause 2		Other
ActionLetters 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 Commerce68
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.
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