Z-2468-2012Class II

TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross...

Name: Z-2468-2012 TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross...
Creator: Toshiba American Medical Systems Inc
Published: 2008-05-13
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2008-05-13 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a... on 2008-05-13. FDA classified it as Class II and gives the reason as "The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function". 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-2468-2012
Classification: Class II
Status: Terminated
Initiated: 2008-05-13
Posted: 2012-09-27
Terminated: 2012-09-27
Recalling firm: Canon Medical Systems USA, Inc.
Product: TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.
Root cause tag: software
FDA root cause: Software design
Action: Toshiba American Medical Systems, Inc. sent an "URGENT: MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. customers: The firm advised customers to take the following temporary measures to avoid issues until a corrective action has been taken: I. In SureStart: " Perform scanning with Observation Direction set to VFF when the Patient Insertion Direction and Observation direction are FF. " Perform scanning with the Observation direction set to VFH when the Patient Insertion Direction and Observation Direction are HF. 2. When acquiring images for 4D perfusion analysis: " Perform scanning with the Scan Direction set to OUT when the Patient Insertion Direction and Scan Direction are HF. Perform scanning with the scan direction set to IN when the Patient Insertion Direction and Scan Direction are FF. Contact the firm at (800) 421-1968 for questions regarding this issue.
Quantity in commerce: 3 units
Distribution: Nationwide distribution: USA including states of: MA, MD, and NV.
Product codes and lots: Item number TSX-301 A/2D Serial Numbers: 2DA0792004, 2DA07X2005, 2DA07Y2010, 2DA0792002, 2DA07X2008, 2DA0842023.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2468-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2468-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-27

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)