CLASS II Device recall · Reported 3 Dec 2014 · FDA Enforcement Report

Cardiac Function Analysis recalled by Toshiba American Medical

Toshiba American Medical Systems is recalling Cardiac Function Analysis, distributed nationwide in the US. The recall was initiated on 5 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem CFA Software Serial Number: Description TSX-301A/2D 1BA07X2002 Aquilion One TSX-301A/2D 1BA07X2001 Aquilion One

Quantity recalled2 units within the U.S. only

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0472-2015
FDA event ID: 69748
Recalling firm: Toshiba American Medical Systems, Tustin, CA
Classification: Class II
Status: Terminated
Recall initiated: 5 Nov 2014
FDA classified: 26 Nov 2014
Reported: 3 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

5 Nov 2014	Recall initiated by company
26 Nov 2014	Classified by FDA	+21 days
3 Dec 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide Distribution to CA, MA, MD

Nationwide California Massachusetts Maryland

Questions about this recall

Is Cardiac Function Analysis recalled?

Yes. Toshiba American Medical Systems recalled Cardiac Function Analysis on 5 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0472-2015.

Why was it recalled?

Which lots are affected?

Item CFA Software Serial Number: Description TSX-301A/2D 1BA07X2002 Aquilion One TSX-301A/2D 1BA07X2001 Aquilion One

Where was it sold?

US Nationwide Distribution to CA, MA, MD

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Toshiba American Medical Systems

All 57

Reported	Class	Recall	Company	Reason	Where
4 Jul 2018Device	CLASS II	Diagnostic Ultrasound System, Aplio I-series recalled	Toshiba American Medical Systems	Device Malfunction	Nationwide
14 Mar 2018Device	CLASS II	Infx-8000V Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA
14 Mar 2018Device	CLASS II	Infx-8000H Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA
14 Mar 2018Device	CLASS II	Infx-8000F Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA
14 Mar 2018Device	CLASS II	Infx-8000C Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA

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