Events

Rappel de Device Recall iba COMPASS SW Version 3.0

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 Iba Dosimetry Gmbh.

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
    66808
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0456-2014
  • Date de mise en oeuvre de l'événement
    2013-08-20
  • Date de publication de l'événement
    2013-12-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123519
  • 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
    Accelerator liner medical - Product Code IYE
  • Cause
    The development partner of iba informed that there is problem in a sw component used in compass when converting region of interest (roi) geometries to dose grid representation. under certain conditions this problem generates too large roi voxel volumes causing erroneous dose statistics and dvhs.
  • Action
    Iba sent an Field Safety Notice on August 20, 2013, by email and letter delivered by UPS, Please distribute this notice to all those who need to be aware within your area of responsibility where the affected software have been installed (e.g. colleagues, satellites). Please maintain awareness of this notice and resulting action until we have provided you with a new software version. We would kindly ask you to acknowledge the receipt of this Field Safety Notice. Please sign and send back the attached Confirmation of Receipt within four weeks after the receipt of this Field Safety Notice. We deeply apologize for the inconvenience. We are working on a new software version with corrected functionality. This should become available during next fall and we will ship it to you as soon as it is released, together with the installation and verification instructions. Should you have questions or require additional information, please contact the Customer Service Team at: Service Department IBA Dosimetry GmbH Bahnhofstrasse 5 DE-90592 Schwarzenbruck, Germany Tel.:+49 9128 607 38 Fax: + 49 9128 607 26 Email: service@iba-group.com .

Device

Device Recall iba COMPASS SW Version 3.0
  • Modèle / numéro de série
    SW Version 3.0. Catalong Number CS10-100
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of CT, MA, OH, CA, SC, NY and OK, and the countries of International distribution (from Germany) Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong and Singapore.
  • Description du dispositif
    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) || radiological
  • Manufacturer
    Iba Dosimetry Gmbh

Manufacturer

Iba Dosimetry Gmbh
  • Adresse du fabricant
    Iba Dosimetry Gmbh, Bahnhofstr. 5, Schwarzenbruck Germany
  • Société-mère du fabricant (2017)
    Ion Beam Applications SA
  • Source
    USFDA