BEUDAMED
    FDA Enforcement Class II Terminated

    Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

    Recall: Z-2769-2017 · Reported August 2, 2017

    Enforcement

    Recall Number
    Z-2769-2017
    Event ID
    77712
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Konica Minolta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 2, 2017
    Initiation Date
    April 24, 2017
    Classification Date
    July 26, 2017
    Termination Date
    January 24, 2018
    Address
    411 Newark Pompton Tpke, N/A, Wayne, NJ, 07470-6657, United States

    Description

    Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

    Reason

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

    Code Info

    UDI 04560141940031 04560141944534 04560141945463 04560141946385 V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)

    Distribution

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

    Quantity

    36 units