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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 Device Recall Toshiba AQUILION ONEsee related information
Date Initiated by FirmSeptember 07, 2010
Date PostedFebruary 15, 2011
Recall Status1 Terminated 3 on April 20, 2012
Recall NumberZ-1257-2011
Recall Event ID 57499
510(K)NumberK083282 
Product Classification X-Ray CT Scanner - Product Code JAK
ProductToshiba 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/
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		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		Software design
ActionToshiba 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 Commerce44 units distributed between 09/2007 - 07/2010
DistributionNationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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