Events

Rappel de Device Recall Proteus 325

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
    67678
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1492-2014
  • Date de mise en oeuvre de l'événement
    2013-12-04
  • Date de publication de l'événement
    2014-04-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126051
  • 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
    Internal testing of the proteus 235 proton therapy system revealed incorrect dose rate calculation in case of beam line option other than zero (0).
  • Action
    Ion Beam Applications ( IBA) sent a recall notification letter dated on/about December 5, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Short term action: A user notice (see annex 1) has been sent to impacted sites where the affected legacy PTS software version was delivered. This user notice explains the workaround required to be put in place in order to fully mitigate the risk and the 1BA action plan to permanently fix this issue. Corrective action: A patch on the PTS Legacy SW was requested and in implementation. In the same time, the solution was put in main code of PTS legacy software version 7 to be integrated in the next release. The customer representative signing underneath confirms that the user notice above is communicated to the appropriate employees. We apologize in advance for any inconvenience this may cause and we would like to thank you for your cooperation. The IBA Site Staff or the Operations manager is available to provide you with additional information and/or guidelines if necessary. Further questions please call : 215-972-7777

Device

Device Recall Proteus 325
  • Modèle / numéro de série
    Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of OK, IL, NJ, and WA.
  • Description du dispositif
    Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. || Proton therapy
  • 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