BEUDAMED
    FDA Enforcement Class II Ongoing

    Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

    Recall: Z-1412-2019 · Reported May 29, 2019

    Enforcement

    Recall Number
    Z-1412-2019
    Event ID
    82662
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elekta Instrument AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2019
    Initiation Date
    June 27, 2018
    Classification Date
    May 23, 2019
    Address
    Kungstensgatan 18, N/A, Stockholm, N/A, N/A, Sweden

    Description

    Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

    Reason

    The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.

    Code Info

    Software Version 11.1

    Distribution

    Worldwide Distribution - US Nationwide distribution to GA, MD, NJ, PA, PR, WA. International distribution to Australia, Belgium, France, Germany, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Romania, Russian Federation, Spain, Turkey, United Kingdom.

    Quantity

    52 devices