BEUDAMED
    FDA Recall Terminated

    RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA. Intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.

    Recall: Z-0853-2011 · Initiated July 21, 2009

    Recall

    Recall Number
    Z-0853-2011
    Event Number
    53047
    Firm
    Accuray Inc
    FEI Number
    1000123585
    Product Code
    JAI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 21, 2009
    Posted
    January 11, 2011
    Terminated
    January 12, 2011
    Address
    1310 Chesapeake Ter, Sunnyvale, CA, 94089-1100

    Description

    RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA. Intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.

    Reason

    Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.

    Action

    Consignees were notified verbally about the issue when an inspection was scheduled.

    Distribution

    Worldwide Distribution -- USA, including states of CA, FL, VA, AL, CT, MA, NC, TN, PA, RI, and NE and countries of Turkey, France, UK, Saudi Arabia, and Switzerland.

    Quantity

    26