BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    Recall: Z-1477-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1477-2018
    Event ID
    79605
    Classification
    Class II
    Status
    Terminated
    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
    May 2, 2018
    Initiation Date
    January 26, 2018
    Classification Date
    April 20, 2018
    Termination Date
    April 27, 2020
    Address
    Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, N/A, Belgium

    Description

    Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    Reason

    When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose.

    Code Info

    Affected version: PTS-7.X.X and PTS-8.X.X Serial numbers PAT.107 (EU); PAT.108, PAT.112, PAT.113, PAT.116 (US)

    Distribution

    Consignees in four states: VA, IL, NJ, and WA. One consignee located in Germany.

    Quantity

    5