BEUDAMED
    FDA Enforcement Class II Ongoing

    Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.

    Recall: Z-1294-2018 · Reported April 11, 2018

    Enforcement

    Recall Number
    Z-1294-2018
    Event ID
    79362
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Seiler Instr. & Mfg. Co. Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 11, 2018
    Initiation Date
    January 1, 2017
    Classification Date
    April 2, 2018
    Address
    3433 Tree Court Industrial Blvd, N/A, Saint Louis, MO, 63122-6617, United States

    Description

    Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.

    Reason

    The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post.

    Code Info

    Model Number 6 ENT

    Distribution

    Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, NV, OK, TX., and to the countries of : Canada, China, Ecuador, England, Greece, Guatemala, Jordan, Lebanon, Mexico, Romania, Russia, South Korea, Taiwan, Japan and United Arab Emirates.

    Quantity

    43 units, but 1 affected