BEUDAMED
    FDA Recall Terminated

    AGFA DX-D 100 is a mobile digital radiography x-ray system

    Recall: Z-1745-2015 · Initiated May 29, 2015

    Recall

    Recall Number
    Z-1745-2015
    Event Number
    71393
    Firm
    AGFA Healthcare Corp.
    FEI Number
    3001236302
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 29, 2015
    Posted
    June 10, 2015
    Terminated
    January 18, 2017
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    AGFA DX-D 100 is a mobile digital radiography x-ray system

    Reason

    When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.

    Action

    AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated May 29, 2015, to all affected customers. The letter was either emailed or sent via FedEx to the US customers. When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur. Please distribute this information within your facility to all those who need to be aware of the notice. Please complete the feedback form as soon as possible and return it to us. We thank you for your careful attention to this issue and your continued support. If you have any questions about this matter, please contact your local Agfa HealthCare organization: 1-877-777-2432 and please reference PR1411200006 and PR1501190003.

    Distribution

    US Distribution to the states of : AL, CA, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WV, WI and WY.

    Quantity

    233 units