BEUDAMED
    FDA Recall Terminated

    HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy

    Recall: Z-2535-2018 · Initiated May 16, 2018

    Recall

    Recall Number
    Z-2535-2018
    Event Number
    80471
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    JAI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 16, 2018
    Terminated
    October 30, 2020
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    Description

    HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy

    Reason

    Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient positioning.

    Action

    The letter from Elekta dated May 2018 was issued via email 5/16/2018 and was flagged "URGENT IMPORTANT FIELD SAFETY NOTIFICATION. The letter identified the affected product, problem and actions to be taken.

    Distribution

    Worldwide Distribution - US Distribution of the device was made nationwide. There was government distribution but no military distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Democratic People's Republic of Korea, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Sweden, Thailand, Turkey, United Kingdom, and Viet Nam.

    Quantity

    725 devices