BEUDAMED
    FDA Enforcement Class II Terminated

    Synaptive ImageDrive Clinical

    Recall: Z-1759-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1759-2020
    Event ID
    85216
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synaptive Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2020
    Initiation Date
    February 26, 2020
    Classification Date
    April 22, 2020
    Termination Date
    April 10, 2024
    Address
    555 Richmond St West, Suite 800, N/A, Toronto, N/A, N/A, Canada

    Description

    Synaptive ImageDrive Clinical

    Reason

    A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.

    Code Info

    ImageDrive Clinical with part number SYN-0578- all versions of the software. With unique device identifier (UDI) #(01) 00670082000139 (10)13x1

    Distribution

    US

    Quantity

    28 units