Recall Z-0472-2015— Toshiba American Medical Systems Inc

Name: FDA recall Z-0472-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-05

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2014-11-05, terminated 2015-10-09. It names one FDA 510(k) clearance: K113466. 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.. Reason: 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..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2014-11-05
Terminated: 2015-10-09
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K113466 — AQUILION ONEToshiba Medical Systems Coporation, Japan·cleared 2012-04-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.