Cl II Toshiba Cardiac Function Analysis Software

Company: Toshiba American Medical Systems Inc.
Date of Enforcement Report 12/3/2014
Class lI:

PRODUCT

Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C 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. The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations. Recall Number Z-0471-2015

REASON
This recalled is being issued due to a potential problem with the cardiac function analysis software (CFA). It has been found that, due to the problem with the software, 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.

RECALLING FIRM/MANUFACTURER
American Medical Systems Inc., Tustin CA 11/5/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1 unit within the U.S. only

DISTRIBUTION
Nationwide Distribution to CA, MA, MD

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