Events

Rappel de Device Recall adaPT insight (12C), v1.3.2

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
    69781
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0836-2015
  • Date de mise en oeuvre de l'événement
    2014-11-07
  • Date de publication de l'événement
    2014-12-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131533
  • 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
    Two issues were identified: 1. in the release of adapt insight v1.3.2., the kv/kv single source acquisition workflow was linked to a wrong geometrical calibration file, resulting in an alignment offset for this specific mode of acquisition. 2. a gantry collision incident required the iba service team to verify the gantry alignment and protons i x-ray beams colinearity, du.
  • Action
    The firm, IBA, sent a " User Notice" dated November 7, 2014, to the sole affected site-UPHS Customer. The notice describes the product, problem and actions to be taken. The customer was instructed that the KV/kV source acquisition mode has been disabled and shall not be used for patient alignment until system is officially confirmed to be back within tolerances. IBA will change the kV/kV Single Source acquisition workflow configuration file to be linked to the correct geometrical calibration file and will update the kV/kV Single Source calibration file that includes the colinearity parameters, with the correct values. If you need assistance, contact the IBA Site Staff or the Operations manager at +32 10 475 997 or email: Sophie.dessart@iba-group.com.

Device

Device Recall adaPT insight (12C), v1.3.2
  • Modèle / numéro de série
    PAT.109 (US), Treatment room 4
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution in PA only.
  • Description du dispositif
    adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C 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 device.
  • 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