BEUDAMED
    FDA Enforcement Class II Terminated

    Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land¿¿ marks.

    Recall: Z-0526-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0526-2015
    Event ID
    69637
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Varian Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 24, 2014
    Initiation Date
    April 30, 2014
    Classification Date
    December 16, 2014
    Termination Date
    March 16, 2015
    Address
    911 Hansen Way, N/A, Palo Alto, CA, 94304-1028, United States

    Description

    Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land¿¿ marks.

    Reason

    Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the EMIbraid on the induc­ tion assembly cable and the ground stud on the lid of the High Voltage Module.

    Code Info

    Part Number P1003290001

    Distribution

    Worldwide Distribution.

    Quantity

    32 units