BEUDAMED
    FDA Enforcement Class II Terminated

    Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.

    Recall: Z-1600-2020 · Reported April 8, 2020

    Enforcement

    Recall Number
    Z-1600-2020
    Event ID
    85185
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Butterfly Network, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 8, 2020
    Initiation Date
    February 24, 2020
    Classification Date
    March 27, 2020
    Termination Date
    June 12, 2020
    Address
    530 Old Whitfield St, N/A, Guilford, CT, 06437-3441, United States

    Description

    Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.

    Reason

    Distributed without an approved 510(k)

    Code Info

    Software versions 1.13.0, 1.14.0, and 1.15.0 UDI: (01)00866646000206

    Distribution

    US Nationwide distribution.

    Quantity

    15,121 host devices