BEUDAMED
    FDA Enforcement Class II Terminated

    Elekta Precise Treatment Table

    Recall: Z-1238-2015 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-1238-2015
    Event ID
    70458
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2015
    Initiation Date
    January 29, 2015
    Classification Date
    March 19, 2015
    Termination Date
    November 5, 2021
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227, United States

    Description

    Elekta Precise Treatment Table

    Reason

    It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected.

    Code Info

    Precise Treatment Table Serial Numbers: (124001-125803, 125807-880, 125883-899, 125902-917, 125920-949, 125952-963, 125966-1256453, 126158-170, 126174-208, 126212-230, 126232-261, 126269-281, 126293-309,123318-330, 126338-126373, 126375-397, 126400-133999, 213000+)

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution and to the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland and Syria.

    Quantity

    529 US 2951 Worldwide