BEUDAMED
    FDA Recall Open, Classified

    CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

    Recall: Z-0723-2022 · Initiated January 14, 2022

    Recall

    Recall Number
    Z-0723-2022
    Event Number
    89524
    Firm
    Carl Zeiss Meditec, Inc.
    FEI Number
    2918630
    Product Code
    OBO
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    January 14, 2022
    Address
    5300 Central Parkway, Dublin, CA, 94568

    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.

    Action

    On 01/14/22, recall notices were mailed to customers who were asked to do the following: 1. Until further notice, please discontinue the acquisition of the ONH Angiography 4.5x4.5mm Scan. 2. Using the provided software kit(s), install software version 11.5.3 on all affected instruments. You will be receiving one software kit per affected instrument according to our records. An excerpt of the IFU has been included Section 4.7 Update Instrument Software, these instructions apply to all models. Refer to the IFU Section 4 for the full installation instructions. 3. Complete and return the Acknowledgement Form per the instructions in the attachment. In case you no longer have the device, we ask that you inform the recalling firm and forward this letter to the new owner. Customers with additional questions were encouraged to contact customer service at 1-800-341-6968 (select option 1, 1).

    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