BEUDAMED
    FDA Recall 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 · Initiated February 24, 2020

    Recall

    Recall Number
    Z-1601-2020
    Event Number
    85178
    Firm
    Butterfly Network, Inc.
    FEI Number
    3010102386
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    February 24, 2020
    Posted
    March 17, 2020
    Terminated
    June 12, 2020
    Address
    530 Old Whitfield St, Guilford, CT, 06437-3441

    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)

    Action

    Butterfly Network issued a correction notification via email on February 24, 2020 disabling the Auto EF Tool from affected devices operating software versions 1.10.0 through 1.15.0 for all affected US Butterfly iQ users and removed references of the Auto EF Tool from outward marketing platforms. Butterfly Network has notified Affiliate partners to cease marketing the Auto EF Volume Tool until further notice. Questions related to this correction can be sent to Butterfly Network Customer Support via email at [email protected]

    Distribution

    US Nationwide distribution.

    Quantity

    11,183