BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1294-2018 · Initiated January 1, 2017

    Recall

    Recall Number
    Z-1294-2018
    Event Number
    79362
    Firm
    Seiler Instr. & Mfg. Co. Inc.
    FEI Number
    1927430
    Product Code
    EPT
    Status
    Open, Classified
    Root Cause
    Use error
    Initiated
    January 1, 2017
    Address
    3433 Tree Court Industrial Blvd, Saint Louis, MO, 63122-6617

    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.

    Action

    The customer was notified via email on about January 4, 2017. Instructions included that the scope only tips if the user has it extended all the way out and is pulling on the handles of the scope. The end user must not pull on the handles of the scope when it is extended. They were also instructed to educate personnel on this matter. For further questions, please call (314) 968-2282.

    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