BEUDAMED
    FDA Enforcement Class II Terminated

    UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.

    Recall: Z-1341-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1341-2020
    Event ID
    84838
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hitachi Medical Systems America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2020
    Initiation Date
    January 31, 2020
    Classification Date
    February 20, 2020
    Termination Date
    July 31, 2020
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371, United States

    Description

    UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.

    Reason

    These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.

    Code Info

    Serial Number: G3007689, G3007688, G3007687, 206H2628, 206H2629, 206H2630, 206H2620, 206H2621, 206H2622, 206H2623, 206H26224, 206H2625, 206H2626, 206H2627, 205X3897, 205X3898, 205X3899, and 205X3900

    Distribution

    Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to Canada.

    Quantity

    18