BEUDAMED
    FDA Enforcement Class II Terminated

    Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.

    Recall: Z-1714-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1714-2014
    Event ID
    68363
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toshiba American Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2014
    Initiation Date
    May 12, 2014
    Classification Date
    June 4, 2014
    Termination Date
    October 2, 2014
    Address
    2441 Michelle Dr, P.O. Box 2068, Tustin, CA, 92780-7047, United States

    Description

    Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.

    Reason

    Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.

    Code Info

    Serial Numbers: ULD1412014, UUC13Z2011, A4A113Z2001.

    Distribution

    Nationwide Distribution including CA and IN

    Quantity

    2