Events

Recall of AdaPTinsight

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
    80219
  • Event Risk Class
    Class 2
  • Event Number
    Z-2109-2018
  • Event Initiated Date
    2016-10-28
  • 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=164900
  • 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 initiating this recall to address an issue identified with adaptinsight software and to reduce risk related to this problem.
  • Action
    IBA mailed an Urgent Field Safety Notice to affected customers on 10/28/2016 to inform them of the issue. The issue will be solved in AdaPTinsights versions starting from Al 2.0. The solution was to be deployed on impacted IBA Proton Therapy sites by September 2017.

Device

AdaPTinsight
  • Model / Serial
    Affected units: SAT.123, SAT.126, PAT.115, SAT.122 and SBF.101
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of LA, TX, Italy, Sweden and France. Each country's National Competent Authorities were notified of the firm's Field Safety Notice.
  • Product Description
    12C (AdaPTinsight) || Affected component: AdaPTinsight software || Product Usage: || 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation 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