BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1412-2019 · Initiated June 27, 2018

    Recall

    Recall Number
    Z-1412-2019
    Event Number
    82662
    Firm
    Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden
    FEI Number
    3002806883
    Product Code
    IWB
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    June 27, 2018

    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.

    Action

    Elekta initially notified customers on about 06/27/2018 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" LETTER. Instructions included to post the recall notice in a place accessible to all users, e.g. Instructions for Use, until the recall action is closed, advise the appropriate personnel working with the affected device of the recall and the content of the recall notification letter, and complete and return the Acknowledgement Form. Elekta updated their recall strategy on about 11/21/2018 and will be providing all affected customers with software upgrade 11.1.1. Electa service engineers will be pro-actively reaching out to customers to organize a date for installation on all affected devices. An updated recall notification was not sent to customers.

    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