Events

Recall of Proteus One, Proteus Plus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ion Beam Applications S.A..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76977
  • Event Risk Class
    Class 2
  • Event Number
    Z-2097-2017
  • Event Initiated Date
    2017-04-10
  • Event Date Posted
    2017-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154743
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, radiation therapy, charged-particle, medical - Product Code LHN
  • Reason
    A pbs (pencil beam scanning) irradiation may pause for different reasons. after a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.
  • Action
    Target date for software update June 30, 2017. A Field Safety Notice was issued on 4/10/2017 describing the problem and reminding users to follow guidance in the user's manual.

Device

Proteus One, Proteus Plus
  • Model / Serial
    Serial numbers: PAT.003, PAT.006
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL
  • Product Description
    Proton therapy system -Proteus 235 aka Proteus Plus. || A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
  • Manufacturer
    Ion Beam Applications S.A.

Manufacturer

Ion Beam Applications S.A.
  • Manufacturer Address
    Ion Beam Applications S.A., Chemin du Cyclotron, 3, Louvain La Neuve Belgium
  • Manufacturer Parent Company (2017)
    Ion Beam Applications SA
  • Source
    USFDA