BEUDAMED
    FDA Recall Terminated

    CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System

    Recall: Z-1697-2019 · Initiated April 10, 2018

    Recall

    Recall Number
    Z-1697-2019
    Event Number
    82664
    Firm
    Accuray Incorporated
    FEI Number
    3003873069
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 10, 2018
    Terminated
    April 1, 2021
    Address
    1240 Deming Way, Madison, WI, 53717-1954

    Description

    CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System

    Reason

    There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.

    Action

    The firm issued a field safety notice by letter on 04/10/2019. The letter explained the issue and provided safety instructions. All impacted customers with affected systems will be contacted to arrange for a software upgrade.

    Distribution

    US & Italy, United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, United Arab Emirates, Thailand

    Quantity

    43 units