BEUDAMED
    FDA Recall Terminated

    Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers: H14, H18, H27, H29, HCX; part of the Trilogy Radiotherapy Delivery System.

    Recall: Z-3204-2011 · Initiated March 17, 2011

    Recall

    Recall Number
    Z-3204-2011
    Event Number
    58474
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 17, 2011
    Posted
    September 14, 2011
    Terminated
    June 20, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers: H14, H18, H27, H29, HCX; part of the Trilogy Radiotherapy Delivery System.

    Reason

    An improperly installed collimator cover may detach and fall from the machine, potentially striking the patient or nearby personnel.

    Action

    On 3/17/2011, Varian Medical Systems sent an Urgent Medical Device Correction Letter to all affected users, with a description of the problem and user corrective action steps.

    Distribution

    Worldwide distribution including USA, Australia, Argentina, Italy, Morocco, South Korea, Belgium, Canada, Netherlands, Denmark, Japan, Hong Kong, Malaysia, Hungary, New Zealand, Sweden, Taiwan, Switzerland, Romania, Brazil, Slovakia, India, Colombia, UK, Ireland, Spain, Singapore, Martinique, Reunion, Venezuela, Iceland, Portugal, Turkey, Israel, Bahrain, Macau, Chile, Saudi Arabia, Latvia, China, Finland, Kazakhstan, Thailand, France, Poland, and Germany.

    Quantity

    3791 units