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U.S. Department of Health and Human Services

Class 2 Device Recall TSX30IC: AQUlLlON ONE; System, XRay, Tomography, Computed.

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  Class 2 Device Recall TSX30IC: AQUlLlON ONE; System, XRay, Tomography, Computed. see related information
Date Initiated by Firm November 14, 2012
Date Posted April 08, 2013
Recall Status1 Terminated 3 on April 08, 2013
Recall Number Z-1068-2013
Recall Event ID 64673
510(K)Number K122109  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
Code Information Serial No: 1CB1262006
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal.
FDA Determined
Cause 2		 Process design
Action Toshiba American Medical Systems Inc. sent a Urgent Medical Device Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer was informed a New software to prevent the occurrence of this issue will be installed on your system. Toshiba Service Representative will contact you for an appointment to install the New Software on your Aquilion One System. Please fax the return reply form to (877) 349-3054. We thank you for your urgent attention to this matter. If you have any further questions regarding this letter please call (800) 521-1968.
Quantity in Commerce 1 unit
Distribution Distributed in the state of MD.
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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