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U.S. Department of Health and Human Services

Class 2 Device Recall Toshiba AQUILION ONE

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 Class 2 Recall
see related information
Date Posted February 15, 2011
Recall Status1 Terminated on April 20, 2012
Recall Number Z-1257-2011
Recall Event ID 57499
Premarket Notification
510(K) Number
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner
Code Information Affected Serial No.: 2DA0872038, 2DA0962116, 2DA0862034, 2DA09Z2161, 2DA07X2008, 2DA1012165, 2DA08X2072, 2DA09Y2151, 2DA0842023, 2DA07X2005, 2DA1012168, 2DA08X2067, 2DA0882053, 2DA0862036, 2DA08Z2092, 2DA0882051, 2DA09Z2162, 2DA1072211, 2DA09X2143, 2DA08Y2077,2DA09X2139, 2DA08X2070, 2DA0982133 2133, 2DA0842026, 2DA0882052, 2DA0972123, 2DA08Y2080, 2DA0882048, 2DA08X2063, 2DA09Y2148, 2DA1012170, 2DA08X2071, 2DA1012169, 2DA0952115, 2DA0982131, 2DA07Y2010, 2DA08X2061, 2DA1012167, 2DA0882049, 1DA0962006, 1DA09Y2014, 1DA0992011, 1DA0972007, 1DA0972008, 2DA1012166, 2DA09Z2158, 2DA1072212, 2DA1012174, 2DA0792004, 2DA1062208, 2DA0792002, 1DA1062015, 1DB1072012
Recalling Firm/
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92781-2068
Manufacturer Reason
for Recall
Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV. This results in a pre-scan expected dose that is approximately 10% lower than what the displayed value should be when the scanner executes the exam Plan.
FDA Determined
Cause 2
DESIGN: Software Design
Action Toshiba America Medical Systems (TAMS) issued notification to consignees 9/7/2010, via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification.
Quantity in Commerce 44 units distributed between 09/2007 - 07/2010
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.