BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2206-2015 · Initiated May 22, 2015

    Recall

    Recall Number
    Z-2206-2015
    Event Number
    71696
    Firm
    American Science & Engineering, Inc.
    FEI Number
    1215713
    Product Code
    RCG
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    May 22, 2015
    Posted
    August 14, 2015
    Terminated
    February 22, 2017
    Address
    829 Middlesex Tpke, Billerica, MA, 01821-3907

    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.

    Action

    American Science Engineering, Inc (AS&E) is developing a fix for this problem that includes updating a software configuration on the X-ray source. You will be notified by field service as soon as this update is available. Please inform all operators of the system about this communication, so they are aware of the need to shut down and re-start the system should this fault occur. We appreciate your understanding. if you have any questions, please feel free to contact AS&E via e-mail at [email protected]. If you are under a service contract, you can also contact your customer service representative. For further questions please call (978) 262-8700.

    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