Z-2339-2010

Toshiba Aquilion ONE CT SystemTSX-301 A/2D

Name: Z-2339-2010 Toshiba Aquilion ONE CT SystemTSX-301 A/2D
Creator: Toshiba American Medical Systems Inc
Published: 2009-02-03
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2009-02-03 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba Aquilion ONE CT SystemTSX-301 A/2D on 2009-02-03. The reason FDA records is "ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB". 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-2339-2010
Status: Terminated
Initiated: 2009-02-03
Posted: 2010-09-01
Terminated: 2011-09-02
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba Aquilion ONE CT SystemTSX-301 A/2D
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB.
Root cause tag: software
FDA root cause: Software design
Action: Toshiba America Medical System Inc (TAMS) sent an Urgent: Medical Device Correction dated January 14, 2009 to their consignees. The letter described the issue and provided instructions to test the device to determine if it is an affected device. If the device is affected, contact the Toshiba service representative at 800 521-1968. Consignees were requested to complete and fax a response form to Toshiba.
Quantity in commerce: 16
Distribution: Nationwide Distribution: including the states of AL, CA, FL, GA, KY, MA, MD, MT, NV, NY, OH, PA, and Puerto Rico.
Product codes and lots: 2DA0872038, 2DA0862034, 2DA07X2008, 2DA0842023, 2DA07X2005, 2DA0882053, 2DA0882051, 2DA0862036, 2DA0882049, 2DA0882052, 2DA0842026, 2DA07Y2010, 2DA0882048, 2DA08X2061, 2DA0792004, and 2DA0792002

Product code JAK

K072606Class IIAquilion One Tsx-301A/2 Computed Tomography SystemToshiba America Medical Systems, In.C / cleared 2007-10-02

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)