BEUDAMED
    FDA Enforcement Class II Terminated

    EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

    Recall: Z-0123-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0123-2022
    Event ID
    88728
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Ultrasound Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 27, 2021
    Initiation Date
    September 21, 2021
    Classification Date
    October 15, 2021
    Termination Date
    April 12, 2024
    Address
    22100 Bothell Everett Hwy, N/A, Bothell, WA, 98021-8431, United States

    Description

    EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

    Reason

    Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided TEE with EchoNavigator, if secondary screen capture is enabled and user presses other system buttons before secondary capture completed.

    Code Info

    Software Versions: 6.0, 7.0, 7.0.3

    Distribution

    US: MI, AZ, IA, TN, OH, CO, WI, NY, NJ, NC, LA, IL, CA, KY, IN, MD, TX, PA. OUS: Denmark, Latvia, Belgium, Hungary, Argentina, Canada, Spain, Germany, Greece, Korea, Republic of Japan, France, Australia, Egypt, Switzerland, Italy, Senegal, Israel, Indonesia, Netherlands, Hong Kong, United Kingdom, Poland, Finland, India, New Zealand

    Quantity

    107