BEUDAMED
    FDA Recall Open, Classified

    Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

    Recall: Z-2406-2021 · Initiated July 26, 2021

    Recall

    Recall Number
    Z-2406-2021
    Event Number
    88451
    Firm
    Elekta Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 26, 2021
    Address
    1450 Beale St, Ste 205, Saint Charles, MO, 63303

    Description

    Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

    Reason

    If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.

    Action

    Elekta will send an Important Field Safety Notice 382-01-MON-019 to all affected customers beginning August 10, 2021. The notice informs users of the specific product and version numbers affected by the issue, and any workaround that can be used to avoid the issue. A copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. Customers are asked to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as possible, but no later than 30 days after receipt. This issue is expected to be addressed in a future Monaco release, tentatively scheduled for the end of June 2022.

    Distribution

    Distribution in US - IA, NJ, NY, TN, PA, TX, and WI OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom