BEUDAMED
    FDA Recall Terminated

    NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.

    Recall: Z-0771-2020 · Initiated February 25, 2019

    Recall

    Recall Number
    Z-0771-2020
    Event Number
    84112
    Firm
    Nidek, Inc.
    FEI Number
    2936921
    Product Code
    NQE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 25, 2019
    Terminated
    June 15, 2021
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    Description

    NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.

    Reason

    The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)

    Action

    The recalling firm issued letters dated 2/7/2019 via FedEx explaining the issue, informing the consignee there was no risk associated with use of the device, and that the firm is preparing for the replacement parts in order to schedule for the correction to be made.

    Distribution

    US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR.

    Quantity

    13 devices