BEUDAMED
    FDA Recall Terminated

    Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

    Recall: Z-2769-2017 · Initiated April 24, 2017

    Recall

    Recall Number
    Z-2769-2017
    Event Number
    77712
    Firm
    Konica Minolta, Inc.
    FEI Number
    2241281
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 24, 2017
    Terminated
    January 24, 2018
    Address
    411 Newark Pompton Tpke, Wayne, NJ, 07470-6657

    Description

    Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

    Reason

    The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.

    Action

    Konica Minolta notified their customers on April 24, 2017.

    Distribution

    CA, CO, KY, FL, NJ, NY, IA TX, & WA

    Quantity

    36 units