Events

Recall of The Proton Therapy System Proteus 235 (brand names: Proteus Plus and Proteus ONE)

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
    80217
  • Event Risk Class
    Class 2
  • Event Number
    Z-2284-2018
  • Event Initiated Date
    2016-04-11
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164898
  • 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
    Iba is conducting a voluntary recall to address a pts (proton therapy system) software issue and to reduce the risk related to this issue.
  • Action
    IBA mailed an Urgent Field Safety Notice to affected customers to inform them and prevent risk associated with this issue. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. A software upgrade will be deployed on impacted units to correct this issue.

Device

The Proton Therapy System Proteus 235 (brand names: Proteus Plus and Proteus ONE)
  • Model / Serial
    PAT.003 and PAT.006
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Units were distributed to Korea and Jacksonville, FL.
  • Product Description
    The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) || Proteus 235, Beam Management System (PBS)
  • 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