BEUDAMED
    FDA Recall Open, Classified

    Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"

    Recall: Z-2227-2021 · Initiated July 8, 2021

    Recall

    Recall Number
    Z-2227-2021
    Event Number
    88109
    Firm
    Carl Zeiss Meditec, Inc.
    FEI Number
    2918630
    Product Code
    OBO
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    July 8, 2021
    Address
    5160 Hacienda Dr, Dublin, CA, 94568-7562

    Description

    Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"

    Reason

    Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.

    Action

    On 07/08/2021 the firm sent an "Medical Device Recall" Notification Letter via UPS informing customers that it commercialized in the U.S. a device without receiving a substantial equivalence clearance [510(k)]. The Recalling Firm is informing and instructing its customers, that while it is working on submitting and received a 510(k) clearance, the affected system may continued to be used as normal. The Recalling Firm has placed a ship hold on all distribution for the U.S. market, but will continue to provide product support for current customers. Customers are also instructed to complete and return the Acknowledgement and Receipt Form via email at [email protected] or via Fax at 925-448-3880. For any questions, contact Customer Service at 877-486-7473.

    Distribution

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

    Quantity

    914 systems