BEUDAMED
    FDA Enforcement Class II Terminated

    Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

    Recall: Z-1440-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1440-2013
    Event ID
    65109
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carl Zeiss Meditec, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    April 18, 2013
    Classification Date
    May 31, 2013
    Termination Date
    June 26, 2013
    Address
    5160 Hacienda Dr, N/A, Dublin, CA, 94568-7562, United States

    Description

    Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

    Reason

    Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount.

    Code Info

    Serial Numbers: 6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813

    Distribution

    US Nationwide Distribution.

    Quantity

    6 units