BEUDAMED
    FDA Enforcement Class II Terminated

    Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.

    Recall: Z-1103-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1103-2013
    Event ID
    63856
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    December 10, 2012
    Classification Date
    April 12, 2013
    Termination Date
    August 1, 2013
    Address
    311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States

    Description

    Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.

    Reason

    Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT.

    Code Info

    Software Versions 5.0.1 and 5.0.2.

    Distribution

    Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.

    Quantity

    11 XKnife V5.0.1 and 1 XKnife V5.0.2