BEUDAMED
    FDA Recall Terminated

    Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA Treatment Planning System is intended as aid in quickly and precisely planning the radiation treatment of small cranial lesions such as an asteriovenous malformations, pituitar tumors, pincalomas, acoustic neuromas and malignant neoplasms.

    Recall: Z-0836-2011 · Initiated March 23, 2010

    Recall

    Recall Number
    Z-0836-2011
    Event Number
    56024
    Firm
    Varian Medical Systems Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 23, 2010
    Posted
    December 29, 2010
    Terminated
    February 24, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA Treatment Planning System is intended as aid in quickly and precisely planning the radiation treatment of small cranial lesions such as an asteriovenous malformations, pituitar tumors, pincalomas, acoustic neuromas and malignant neoplasms.

    Reason

    Due to software Issue, an error occurs when performing cone planning using MRI, which may result in the patient receiving a higher radiation dose than expected, potentially to healthy tissue.

    Action

    Varian sent Urgent Medical Device Correction letters on March 23, 2010, by Federal Express to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to run test cases or otherwise determine whether the MR images that they receive have the 'Series Date' parameter populated. Customers should contact their MR system manufacturer to get a confirmation that the 'Series Date' field is populated. Customers were instructed to confirm by visual inspection that the fusion results are loaded appropriately in Cone Planning before starting to create or edit a plan. For questions regarding this recall contact your local Varian Customer Support Distirct or Regional Manager. Phone: USA and Canada - 1-888-VARIANS (888-827-4265) Europe -+41 41 749 8844 E-mail: North America: [email protected] Australia/New Zealand: [email protected] Europe: [email protected] South East Asia: [email protected] China/Asia: [email protected] Japan: [email protected] Latin America: [email protected] Internet: Oncology Systems customer site - www.myvarian.com Varian Medical System public site - www.varian.com

    Distribution

    Worldwide distribution - USA nationwide and the countries of Australia, Brazil, Canada, Chile, Colombia, Georgia, Germany, Hong Kong, India, Ireland, Japan, Macau, Malaysia, Russia, Singapore, Spain, Sri Lanka, and Taiwan

    Quantity

    218 units