BEUDAMED
    FDA Recall Terminated

    Varian Medical Systems, Inc. Eclipse/VARiS Vision, an Eclipse radiotherapy Treatment Planning System (Eclipse TPS); Eclipse Version 7.3.10 (multiple workstations) VARiS Vision System 7. x; Model Numbers: H48/H83.

    Recall: Z-0455-2011 · Initiated May 13, 2010

    Recall

    Recall Number
    Z-0455-2011
    Event Number
    56012
    Firm
    Varian Medical Systems Oncology Systems
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 13, 2010
    Posted
    November 24, 2010
    Terminated
    February 24, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian Medical Systems, Inc. Eclipse/VARiS Vision, an Eclipse radiotherapy Treatment Planning System (Eclipse TPS); Eclipse Version 7.3.10 (multiple workstations) VARiS Vision System 7. x; Model Numbers: H48/H83.

    Reason

    Incorrect treatment plan or record: A software design deficiency has the potential for corrupted treatment plan records or treatment records in cases where multiple users editing a record simultaneously can result in a corrupted (but accessible) treatment plan record.

    Action

    On May 13, 2010, the firm issued letters to all its direct consignees, informing them of the affected products and providing instructions on the recall. ***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.***

    Distribution

    Nationwide and Worldwide

    Quantity

    2417 units***12-20-12 AMENDED TO: 49 units***