BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus ONE and Proteus Plus

    Recall: Z-2139-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2139-2018
    Event ID
    80221
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    September 16, 2016
    Classification Date
    June 8, 2018
    Termination Date
    February 8, 2019
    Address
    Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, N/A, Belgium

    Description

    Proteus ONE and Proteus Plus

    Reason

    IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.

    Code Info

    Code/Serial Numbers: PAT.000, 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, SAT.126, SBF.101

    Distribution

    Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.

    Quantity

    N/A