BEUDAMED
    FDA Recall Terminated

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    Recall: Z-1502-2014 · Initiated March 20, 2014

    Recall

    Recall Number
    Z-1502-2014
    Event Number
    67896
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    March 20, 2014
    Posted
    April 24, 2014
    Terminated
    May 1, 2015
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    Reason

    Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.

    Action

    Varian sent an Urgent Medical Device Correction letters March 20, 2014 to affected custoers via trackable mail. The letter was also distributed to Varian Sales, Marketing and Service organizations to inform them of the issues. The letter identified the affected product, description of problem, details, and recommended user actions to be taken. A Varian Customer Support Service representative will arrange a site visit to check the bel tension of the Type 01 elbow motors. If over tensioned belts are detected, the elbow motor will be replace with a Type O2 elbow motor. Questions may be directed to 888-827-4265.

    Distribution

    Worldwide Distribution.

    Quantity

    2622