BEUDAMED
    FDA Enforcement Class II Terminated

    Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

    Recall: Z-0046-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0046-2020
    Event ID
    83383
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leica Biosystems Imaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2019
    Initiation Date
    December 10, 2018
    Classification Date
    October 4, 2019
    Termination Date
    April 28, 2021
    Address
    1360 Park Center Dr, N/A, Vista, CA, 92081-8300, United States

    Description

    Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

    Reason

    The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images.

    Code Info

    Serial numbers 5899, 5902, and 5986.

    Distribution

    There was no U.S. distribution. Foreign distribution was made to South Korea and the United Kingdom.

    Quantity

    3 devices