BEUDAMED
    FDA Enforcement Class II Terminated

    AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.

    Recall: Z-0934-2015 · Reported January 14, 2015

    Enforcement

    Recall Number
    Z-0934-2015
    Event ID
    70009
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vision Rt Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 14, 2015
    Initiation Date
    November 11, 2014
    Classification Date
    January 7, 2015
    Termination Date
    May 11, 2016
    Address
    8840 Stanford Blvd, N/A, Columbia, MD, 21045-5827, United States

    Description

    AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.

    Reason

    Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.

    Code Info

    Serial numbers (internally referred to as PCR numbers): USA: 247-018, 247-039, 247-040, 247-053, 247-060, 247-061 , 247-062, 247-063, 247-068, 247-071 , 247-075, 247-076 , 247-078, 247-081, 247-083, 247-096, 247-099, 247-100,, 247-101, 247-102 , 247-110 , 247-118, 247-119, 247-122, 247-124, 247-127, 247-129, 247-130, 247-138, 247-140, 247-142, 247-149, 247-150, 247-153, 247-161, 247-167, 247-171, 247-184, 247-194, 247-200, 247-207, 247-212, 247-213, 248-012, 248-018, 248-041 Rest of the world: 247-035, 247-073, 247-114, 247-131, 247-147, 247-148, 247-188

    Distribution

    Nationwide Distribution

    Quantity

    55