Derived label

Device software or design

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.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software (CFA). Incorrect
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Toshiba American Medical Systems Inc