Events

Rappel de Device Recall ProteusONE

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ion Beam Applications S.A..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79229
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0943-2018
  • Date de mise en oeuvre de l'événement
    2017-11-01
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161706
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, radiation therapy, charged-particle, medical - Product Code LHN
  • Cause
    The internal configuration of the electrometers and the real-time control boards of the dekimo scanning controller is not checked before each patient treatment.
  • Action
    The firm, IBA, sent an "Urgent Field Safety Notice" dated 10/31/2017 to customers on 10/31/2017. The notice described the product, problem and actions to be taken. stating the following: There is no specific recommendation for the user. IBA will provide an Internal User notice to the IBA site team, requesting the operator to select the Beam Delivery Point CGTR, by clicking on the BDP button, before each patient treatment preparation (see Annex 1 for details). This will begin the check of the internal configuration of all the elements of the Dekimo Scanning Controller. An updated system will be deployed on February 28, 2017. If you have any questions, contact Customer Complaints & Vigilance Director at Vigilance@iba-group.com or +32 10 203 787 or helpdesk at +32 2 507 20 81 (available 24/7).

Device

Device Recall ProteusONE
  • Modèle / numéro de série
    SBF.101 (EU), SBF.105 (US)
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to: MI only and country of: France.
  • Description du dispositif
    Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 || The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
  • Manufacturer
    Ion Beam Applications S.A.

Manufacturer

Ion Beam Applications S.A.
  • Adresse du fabricant
    Ion Beam Applications S.A., Chemin du Cyclotron, 3, Louvain La Neuve Belgium
  • Société-mère du fabricant (2017)
    Ion Beam Applications SA
  • Source
    USFDA