BEUDAMED
    FDA Enforcement Class II Ongoing

    Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

    Recall: Z-1205-2022 · Reported June 8, 2022

    Enforcement

    Recall Number
    Z-1205-2022
    Event ID
    90213
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 8, 2022
    Initiation Date
    April 20, 2022
    Classification Date
    May 27, 2022
    Address
    3 Chemin Du Cyclotron, N/A, Louvain-la-neuve, N/A, N/A, Belgium

    Description

    Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

    Reason

    First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed

    Code Info

    UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU).

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.

    Quantity

    4 units