BEUDAMED
    FDA Recall Terminated

    OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field.

    Recall: Z-0105-2012 · Initiated September 26, 2011

    Recall

    Recall Number
    Z-0105-2012
    Event Number
    60017
    Firm
    Carl Zeiss Meditec, Inc.
    FEI Number
    2918630
    Product Code
    EPT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 26, 2011
    Posted
    October 24, 2011
    Terminated
    November 4, 2011
    Address
    5160 Hacienda Dr, Dublin, CA, 94568-7562

    Description

    OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field.

    Reason

    An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical microscope distributed to three US locations.

    Action

    Carl Zeiss Meditec had Field Service Engineers directly contact all affected customers. The Field Service Engineers will replace the defective component. Questions regarding this Field Corrective Action should be directed to the Director of Clinical/Regulatory Affairs at 925-557-4616.

    Distribution

    USA (nationwide) including the states of FL, GA, and LA .

    Quantity

    3