BEUDAMED
    FDA Enforcement Class II Ongoing

    Proteus 235-Proton Therapy System

    Recall: Z-2155-2021 · Reported August 4, 2021

    Enforcement

    Recall Number
    Z-2155-2021
    Event ID
    88196
    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
    August 4, 2021
    Initiation Date
    May 26, 2021
    Classification Date
    July 28, 2021
    Address
    Chemin Du Cyclotron 3, N/A, Louvain-la-neuve, N/A, N/A, Belgium

    Description

    Proteus 235-Proton Therapy System

    Reason

    if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position

    Code Info

    Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US).

    Distribution

    FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands

    Quantity

    5 US; 8 OUS