BEUDAMED
    FDA Enforcement Class II Ongoing

    CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

    Recall: Z-0723-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0723-2022
    Event ID
    89524
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Carl Zeiss Meditec, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2022
    Initiation Date
    January 14, 2022
    Classification Date
    March 4, 2022
    Address
    5300 Central Parkway, N/A, Dublin, CA, 94568, United States

    Description

    CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

    Reason

    Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.

    Code Info

    All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan

    Distribution

    U.S Nationwide Distribution.: OH, CA, IN, AR, IA, LA, WI, OK, IL, OR, AL, KY, WY, WA, MN, NE, PA, SD, AZ, PR, TN, GA, FL, DE, NY, NH, TX, MS, MA, NV, UT, WV, ME, CO, AK, NM, KS, MO, MI, MD, ID, CT, NJ, MT, NC, VA, HI, VT, ND, SC, DC, RI

    Quantity

    1,272 devices