BEUDAMED
    FDA Enforcement Class II Terminated

    DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, muscular-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams.

    Recall: Z-1330-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1330-2020
    Event ID
    84794
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2020
    Initiation Date
    January 13, 2020
    Classification Date
    February 20, 2020
    Termination Date
    August 21, 2020
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001, United States

    Description

    DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, muscular-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams.

    Reason

    The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.

    Code Info

    DP-30 Ultrasound with software version 03.00.00 and 03.01.00

    Distribution

    US Nationwide distribution in the states of CA, GA, IL, MD, NY, SC, and WA.

    Quantity

    53 DP-30 systems and 18 USB's containing the affected software