BEUDAMED
    FDA Recall Terminated

    Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications

    Recall: Z-2768-2016 · Initiated August 2, 2016

    Recall

    Recall Number
    Z-2768-2016
    Event Number
    74974
    Firm
    Bayer Healthcare
    FEI Number
    2520313
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 2, 2016
    Terminated
    December 9, 2016
    Address
    1 Bayer Dr, Indianola, PA, 15051-9702

    Description

    Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications

    Reason

    CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.

    Action

    Bayer Healthcare mailed an Urgent Field Safety Notification letter on August 03, 2016 to customers who were affected by the recall informing them of the issue and what actions to take if they were impacted. Customers were advised to use the enclosed Interim Instructions for Use for further information. For questions customers should call 1-877-229-3767.

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to United Arab Emirates, Australia, Canada, Germany, Spain, and United Kingdom.

    Quantity

    165 systems