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U.S. Department of Health and Human Services

Class 2 Device Recall Aquilion CT System TSX302A

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  Class 2 Device Recall Aquilion CT System TSX302A see related information
Date Initiated by Firm May 08, 2015
Date Posted October 09, 2015
Recall Status1 Terminated 3 on October 26, 2016
Recall Number Z-0017-2016
Recall Event ID 71923
510(K)Number K120710  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Toshiba Aquilion CT System TSX-302A
Code Information system software V6.0 or later
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
PO Box 2068
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Toshiba America Medical Planned Action to bring defect into Compliance: a. A notification will be sent to all consignees with affected systems in compliance with 21 CFR1 003.21 upon approval by the Secretary. b. To correct this issue revised software will be installed on each system to prevent this occurrence from happening. Each consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available. c. Each consignee will be advised to do the following until the corrective measures have been taken, i.e., revised software installed on their systems. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Toshiba America Medical Systems, Inc. will implement this CAP by February 1, 2016. If you have any questions please contact your local Toshiba Representative at (800) 521-1968.
Quantity in Commerce 459
Distribution US Distribution including 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 MEDICAL SYSTEMS CORPORATION
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