BEUDAMED
    FDA Recall Terminated

    CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185, Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA A Radiation therapy device.

    Recall: Z-0908-2011 · Initiated March 16, 2009

    Recall

    Recall Number
    Z-0908-2011
    Event Number
    51550
    Firm
    Accuray Inc
    FEI Number
    1000123585
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 16, 2009
    Posted
    January 18, 2011
    Terminated
    January 19, 2011
    Address
    1310 Chesapeake Ter, Sunnyvale, CA, 94089-1100

    Description

    CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185, Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA A Radiation therapy device.

    Reason

    The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly.

    Action

    Accuracy Inc., sent an URGENT ADVISORY NOTIFICATION letter, dated March 16, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their system to see if it was affected. Customers were instructed to contact Accuracy Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 or e-mail [email protected] to schedule service.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK, Spain, Greece, Switzerland, Germany, India, Taiwan, China, Hong Kong, Korea, Thailand, Malaysia and Japan