BEUDAMED
    FDA Enforcement Class II Ongoing

    Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w

    Recall: Z-0448-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0448-2024
    Event ID
    93320
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AURIS HEALTH INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 13, 2023
    Initiation Date
    October 18, 2023
    Classification Date
    December 1, 2023
    Address
    150 Shoreline Dr, Redwood City, CA, 94065-1400, United States

    Description

    Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w

    Reason

    Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

    Code Info

    Software Version 2.2.4

    Distribution

    US Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WI & WV.

    Quantity

    110 units In total