BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235 and Proteus ONE proton therapy systems

    Recall: Z-2672-2017 · Reported July 12, 2017

    Enforcement

    Recall Number
    Z-2672-2017
    Event ID
    77620
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2017
    Initiation Date
    May 18, 2016
    Classification Date
    July 3, 2017
    Termination Date
    February 8, 2019
    Address
    Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, N/A, Belgium

    Description

    Proteus 235 and Proteus ONE proton therapy systems

    Reason

    Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.

    Code Info

    Code/Serial Numbers: PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123 and SAT.126

    Distribution

    Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden

    Quantity

    18 worldwide and 10, in the U.S.