Z-0472-2015Class II

Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the...

Name: Z-0472-2015 Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the...
Creator: Toshiba American Medical Systems Inc
Published: 2014-11-05
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2014-11-05 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D... on 2014-11-05. FDA classified it as Class II and gives the reason as "Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a...". 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-0472-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-05
Posted: 2014-11-26
Terminated: 2015-10-09
Recalling firm: Canon Medical Systems USA, Inc.
Product: Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters.
Root cause tag: software
FDA root cause: Software design
Action: Toshiba sent an Urgent Medical Device Correction letter dated November 5, 2014, to all affected customers. Customers were asked to refrain from using the function parameters for the entire heart and the left-ventricular volume curve until corrective actions have been taken. Customers were instructed to share this information with all users and reviewing radiologist as well as clinical engineering or Biomedical group at facility. Please complete and return the attached form and fax it to the toll free number at the top of the form 877-349-3054. This form can also be sent via email to [email protected]. Revised software to prevent occurrence of this problem will be installed on the system. When the new software becomes available the Toshiba service representative will contact for an appointment to install it on the system. Customers with questions were instructed to call 800-421-1968 or contact their local Toshiba Representative at 800-521-1968.
Quantity in commerce: 2 units within the U.S. only
Distribution: US Nationwide Distribution to CA, MA, MD
Product codes and lots: Item CFA Software Serial Number: Description TSX-301A/2D 1BA07X2002 Aquilion One TSX-301A/2D 1BA07X2001 Aquilion One

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0472-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0471-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-26
Z-0472-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-26

Product code JAK

K113466Class IIAquilion OneToshiba Medical Systems Coporation, Japan / cleared 2012-04-10

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)