Events

Rappel de Device Recall Proteus Plus and Proteus ONE

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
    77175
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2592-2017
  • Date de mise en oeuvre de l'événement
    2017-02-09
  • Date de publication de l'événement
    2017-06-19
  • 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=155167
  • 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
    It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in pencil beam scanning (pbs) treatment mode when system is not irradiating between layers.
  • Action
    Ion Beam Application S.A. (IBA) will bring the defect into compliance: 1. Providing recommendations for user actions which, if followed, will prevent dark current. In order to prevent the error from occurring, the IBA customers are provided with a specific QA map that would detect dark current and instructions on how and when to use it (Annex 1). This guidance was included in IBAs User Notice which was sent to users on February 9, 2017. 2. IBA is developing a long term solution consisting of a new IC-cyclo (ionization chamber located at the cyclotron exit) and a Beam Absence Electronic Unit (BAEU) along with a software upgrade. This solution will detect presence of dark current between irradiations. It will prevent starting a new irradiation if dark current is present. This solution is currently in test phase and will be completed in two years. 3. Manufacturer will provide the FDA with progress reports on the effectiveness of the plan, including the number of electronic products repaired on a quarterly basis. The first progress report will be provided to the FDA by September 15, 2017 to the correspondence identified below. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2.Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. For further questions please call (571) 449-4992.

Device

Device Recall Proteus Plus and Proteus ONE
  • Modèle / numéro de série
    Serial Numbers: PAT.000,PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.
  • Description du dispositif
    Proteus 235
  • 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