BEUDAMED
    FDA Enforcement Class II 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 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0753-2016
    Event ID
    72515
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Regulatory Insight, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    July 1, 2008
    Classification Date
    February 24, 2016
    Termination Date
    July 11, 2017
    Address
    33 Golden Eagle Ln, N/A, Littleton, CO, 80127-5745, United States

    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.

    Code Info

    NRT no.: 02980000

    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