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U.S. Department of Health and Human Services

Class 2 Device Recall Aquilion One: Aquilion TSX301A

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  Class 2 Device Recall Aquilion One: Aquilion TSX301A see related information
Date Initiated by Firm January 07, 2011
Date Posted July 29, 2011
Recall Status1 Terminated 3 on August 17, 2012
Recall Number Z-2895-2011
Recall Event ID 58031
510(K)Number K083282  
Product Classification X-ray Tomography System - Product Code JAK
Product Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography.
Toshiba American Medical Systems, Inc.

A multislice CT system that supports whole-body scanning.
Code Information 2DA1062208, 2DA107221, 2DA1072212, 2DB1082219, 2DB1082220, 2DB1082222
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		 Toshiba America Medical Systems (TAMS) is initiating a field correction for the TSX-301A and TSX-301B: Aquilion 64 System, X-Ray, Tomography because communication between reconstruction units in the system console may be broken due to failure of the optical conversion connector, resulting in a break of communication between units.
FDA Determined
Cause 2		 Software design
Action Toshiba America Medical Systems, Inc. sent an "Urgent Medical Device Correction" letter dated January 4, 2011 to all affected customers. The letter provides the customers with an explanation of the problem and the firms plan to install preventive measures and provided them with a Customer Reply form to send Toshiba. A representative will contact the customers for an appointment to install the measures to their CT system. For question on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.
Quantity in Commerce 6
Distribution (USA) Nationwide Distribution including the states of WI, MO, TN, IA, AL, AZ, TX, and GA.
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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