BEUDAMED
    FDA Enforcement Class II Ongoing

    Proteus 235- designed 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-2434-2021 · Reported September 15, 2021

    Enforcement

    Recall Number
    Z-2434-2021
    Event ID
    88449
    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
    September 15, 2021
    Initiation Date
    June 14, 2021
    Classification Date
    September 10, 2021
    Address
    Chemin Du Cyclotron 3, N/A, Louvain-la-neuve, N/A, N/A, Belgium

    Description

    Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

    Reason

    Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

    Code Info

    PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.110 (US), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (EU), SBF.109 (UK), SBF.110 (UK), SBF.113 (US), SBF.115 (UK), SBF.117 (EU).

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.

    Quantity

    27 worldwide, 11 in U.S.