BEUDAMED
    FDA Recall Terminated

    Pinnacle3 Radiation Therapy Planning System, Version 6.6c CD, Part Number 9104-0121C Rev. A

    Recall: Z-0914-04 · Initiated March 3, 2004

    Recall

    Recall Number
    Z-0914-04
    Event Number
    28478
    Firm
    ADAC Laboratories
    FEI Number
    3004022368
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 3, 2004
    Posted
    July 20, 2004
    Terminated
    February 1, 2005
    Address
    6400 Enterprise Ln, Ste 201, Madison, WI, 53719-1138

    Description

    Pinnacle3 Radiation Therapy Planning System, Version 6.6c CD, Part Number 9104-0121C Rev. A

    Reason

    A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe.

    Action

    A notification dated March 3, 2004 was sent to the customers. The notification gave recommendations for avoiding the problem and stated that updated software would be provided when it becomes available. Firm representatives made follow-up telephone calls to the consignees.

    Distribution

    The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.

    Quantity

    55