BEUDAMED
    FDA Recall Terminated

    Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, Manufactured by Varian Medical Systems Inc., Palo Alto, CA The Varis RV function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan. Additional applications provide various data management and library functions.

    Recall: Z-1809-2009 · Initiated May 8, 2009

    Recall

    Recall Number
    Z-1809-2009
    Event Number
    52654
    Firm
    Varian Medical Systems Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 8, 2009
    Posted
    August 27, 2009
    Terminated
    December 23, 2011
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, Manufactured by Varian Medical Systems Inc., Palo Alto, CA The Varis RV function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan. Additional applications provide various data management and library functions.

    Reason

    Potential mistreatment-- due to software issues, retired plans may be used and treated repeatedly.

    Action

    An Urgent Medical Device Correction Letter/ Field Safety Letter, dated May 8, 2009, were distributed to all affected users, with a description of the problem and user corrective action steps. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm intends to produce a software fix for the problem. If further clarification is needed, users should contact their Varian Customer Support District or Regional Manager.

    Distribution

    Worldwide Distribution

    Quantity

    1,587 units