BEUDAMED
    FDA Enforcement Class II Terminated

    Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of anatomical structures.

    Recall: Z-1601-2020 · Reported April 8, 2020

    Enforcement

    Recall Number
    Z-1601-2020
    Event ID
    85178
    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 containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of anatomical structures.

    Reason

    Distributed without an approved 510(k)

    Code Info

    Software versions 1.10.0 through 1.15.0

    Distribution

    US Nationwide distribution.

    Quantity

    11,183