Z-1257-2011

Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner

Name: Z-1257-2011 Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner
Creator: Toshiba American Medical Systems Inc
Published: 2010-09-07
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2010-09-07 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner on 2010-09-07. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1257-2011
Status: Terminated
Initiated: 2010-09-07
Posted: 2011-02-15
Terminated: 2012-04-20
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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

Product code JAK

K083282Class IIModel Tsx-301B Aquilion CT SystemToshiba America Medical Systems, In.C / cleared 2008-12-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)