BEUDAMED
    FDA Recall Terminated

    Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems, Inc. Oncology Systems Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions in the body where radiation treatment is indicated.

    Recall: Z-2978-2011 · Initiated May 26, 2011

    Recall

    Recall Number
    Z-2978-2011
    Event Number
    59087
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 26, 2011
    Posted
    August 10, 2011
    Terminated
    July 13, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems, Inc. Oncology Systems Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions in the body where radiation treatment is indicated.

    Reason

    On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions.

    Action

    Varian Medical Systems sent an "Urgent Medical Device Correction-Urgent Field Safety Notice" letter dated May 26, 2011 to all affected customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letters identifies the product, describes the problem and provides recommendations. Varian recommends maintenance only be performed by qualified personnel with appropriate training, always verify collimator calibration and anytime a collimator posthion readout calibration is performed, and always verify that the collimator angle is not calibrated in reverse by performing the appropriate checks. For questions contact Varian at (888) 827-4265.

    Distribution

    Worldwide Distribution: Nationwide (USA) Distribution and the countries of; Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Belorussia, Bolivia, Bosnia and Herzegoniva, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Rep., Denmark, D.R. Ecuador, Egypt, Estonia, Finland, France, French Poly., Georgia, Germany, Greece, Guam, Guatemala, H.K., Honduras, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Martinique, Mexico, Moldova, Monte Negro, Morocco, Nepal, Netherlands, N.Z., Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, P.R., Qatar, Reunion, Romania, Russia, S.A.,Serbia, Singapore, Slovakia, South Africa, S.K., Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad/Tobago, Tunisia, Turkey, Ukrain, U.A.E., U.K., Uruguay, Venezuela, Vietnam, V.I., and Zimbabwe.

    Quantity

    5685