BEUDAMED
    FDA Recall Terminated

    Elekta Precise Treatment Table

    Recall: Z-1238-2015 · Initiated January 29, 2015

    Recall

    Recall Number
    Z-1238-2015
    Event Number
    70458
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    JAI
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 29, 2015
    Posted
    March 19, 2015
    Terminated
    November 5, 2021
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

    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.

    Action

    Planned Action by Elekta: 1. Notifications have been sent out. The notification informs users of the possibility treatment table position errors might occur if there is a maintenance error when replacing a potentiometer. The notification recommends establishing a procedure to verify the accuracy of the treatment table position as shown by the treatment room monitor which is performed as part of the daily machine checks. An example procedure is provided. 2. Elekta will establish a procedure service engineers will follow after maintenance involving the relevant potentiometers to ensure proper installation. The procedure will be taught using a video which includes a step by step guide to the correct methodology for installation of the potentiometer assembly, a description of the impact for not installing correctly, and a guide to the new verification of correct installation procedure. The video will be distributed through Elektas learning management system (LMS). The LMS maintains a record of service engineers who successfully complete the training. 3. Elekta will implement an engineering change to the potentiometer assembly which applies to the manufacture of all new Precise Treatment Tables. This change will eliminate the potential for incorrect installation and will prevent a loose grub screw from causing backlash. This change is expected to consist of a 'D' shaped bore that cannot spin on the shaft of the potentiometer. All actions associated with this correction, including service engineer training, will be completed by June 2015. For further questions please call (770) 300-9725.

    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