BEUDAMED
    FDA Recall 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 · Initiated January 13, 2020

    Recall

    Recall Number
    Z-1330-2020
    Event Number
    84794
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    FEI Number
    2221819
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    January 13, 2020
    Posted
    February 5, 2020
    Terminated
    August 21, 2020
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001

    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.

    Action

    On January 13, 2020, the firm distributed Urgent Medical Device Correction letters to affected distributors. Distributors were informed that the system displays the incorrect needle-guide bracket when used with the 65EC10EA model transducer. Customers were advised to avoid use of NGB-004 needle-guide with transducer model 65EC10EA until a software update has been applied to the system. The system may be used normally for all other functions. The firm recommended that distributors immediately notify any clients to which they have distributed affected systems (DP-30 systems with software version 03.00.00 and 03.01.00 distributed between 06/25/2018 and 06/28/2019), or provided a software update (USB with V03.01.00, part number 110-002261-05). Within the next several weeks, Mindray will provide a software update at no cost. Should you require technical assistance while performing the update, please contact Mindrays Technical Support team at 800-288-2121, option 2, Monday through Friday, 8:30am - 5:30pm PT. The replacement USB drive contains instructions on how to perform the software update, under the Manuals folder in the DP-10 & DP-20 & DP-30 Series System Recovery Guide file. If you have questions regarding this recall, you may contact Diane Arpino, Director, Quality Operations and Regulatory Affairs, at 201-995-8407, or via email at [email protected].

    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