BEUDAMED
    FDA Enforcement Class II Terminated

    American Science & Engineering Inc,Gemini Cabinet X-ray system.

    Recall: Z-2206-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2206-2015
    Event ID
    71696
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    American Science & Engineering, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2015
    Initiation Date
    May 22, 2015
    Classification Date
    August 14, 2015
    Termination Date
    February 22, 2017
    Address
    829 Middlesex Tpke, Billerica, MA, 01821-3907, United States

    Description

    American Science & Engineering Inc,Gemini Cabinet X-ray system.

    Reason

    During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault that leads to a state in which X-rays are being produced but the X-ray indicator lights (located on the operator's console and on both ends of the tunnel) are not illuminated.

    Code Info

    Gemini systems

    Distribution

    Worldwide Distribution - US Distribution to the states of : NY, FL, TN, PA, NJ, DE, ME, TX, CT, MS, NC, MD, MO, VA, DC, NV and GA., and to the countries of : Saudi Arabia, Indonesia, Canada, Netherlands, Hong Kong, Lebanon and Kazakhstan.

    Quantity

    125 systems