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U.S. Department of Health and Human Services

Class 2 Device Recall Aquilion ONE CT System TSX301 A/2D

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  Class 2 Device Recall Aquilion ONE CT System TSX301 A/2D see related information
Date Initiated by Firm February 03, 2009
Date Posted September 01, 2010
Recall Status1 Terminated 3 on September 02, 2011
Recall Number Z-2339-2010
Recall Event ID 52830
510(K)Number K072606  
Product Classification System, x-ray, tomography x-ray, computed - Product Code JAK
Product Toshiba Aquilion ONE CT SystemTSX-301 A/2D
Code Information 2DA0872038, 2DA0862034, 2DA07X2008, 2DA0842023, 2DA07X2005, 2DA0882053, 2DA0882051, 2DA0862036, 2DA0882049, 2DA0882052, 2DA0842026, 2DA07Y2010, 2DA0882048, 2DA08X2061, 2DA0792004, and 2DA0792002
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB.
FDA Determined
Cause 2		 Software design
Action Toshiba America Medical System Inc (TAMS) sent an Urgent: Medical Device Correction dated January 14, 2009 to their consignees. The letter described the issue and provided instructions to test the device to determine if it is an affected device. If the device is affected, contact the Toshiba service representative at 800 521-1968. Consignees were requested to complete and fax a response form to Toshiba.
Quantity in Commerce 16
Distribution Nationwide Distribution: including the states of AL, CA, FL, GA, KY, MA, MD, MT, NV, NY, OH, PA, and Puerto Rico.
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 = JAK and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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