BEUDAMED
    FDA Recall Terminated

    GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.

    Recall: Z-0753-2016 · Initiated July 1, 2008

    Recall

    Recall Number
    Z-0753-2016
    Event Number
    72515
    Firm
    Regulatory Insight, Inc
    FEI Number
    3011361886
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    July 1, 2008
    Posted
    February 24, 2016
    Terminated
    July 11, 2017
    Address
    33 Golden Eagle Ln, Littleton, CO, 80127-5745

    Description

    GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.

    Reason

    It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.

    Action

    Nordisk Rontgen Teknik ( NRT ) Planned action to bring defect into compliance: 1.Nordisk Rontgen Teknik A/S (NRT) will contact customers and initiate a software and hardware update to correct the defect. 2.NRT engineers will install the software and perform testing to ensure the software and hardware update was effective. 3.The customer notification letter which includes a statement that NRT will without charge, remedy the defect or bring the product into compliance. For further questions please call (720) 962- 5412.

    Distribution

    US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.

    Quantity

    43