Events

Recall of Device Recall 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
    76804
  • Event Risk Class
    Class 2
  • Event Number
    Z-1830-2017
  • Event Initiated Date
    2017-03-21
  • 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=154230
  • 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
    radiation therapy system - Product Code LHN
  • Reason
    In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
  • Action
    A Field Safety Notice was mailed to the customer affected by the issue on 03/21/2017. The Notice informed the user when resuming from a partial irradiation, to ensure that the correct delivered dose has been selected in the partial report dialog box before proceeding with irradiation.

Device

Device Recall Proteus Plus
  • Model / Serial
    Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution in US (to Louisiana), and France.
  • Product Description
    Proteus 235, Proton Therapy System
  • 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