Events

Rappel de Device Recall COMPASS SW Version 3.1, Catalog Number CS10100

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
    70545
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1212-2015
  • Date de mise en oeuvre de l'événement
    2015-02-02
  • Date de publication de l'événement
    2015-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134007
  • 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, linear, medical - Product Code IYE
  • Cause
    Error in the software. during internal tests of the current development version of the compass sw it was found that dose reconstruction for dmlc plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.
  • Action
    IBA sent an Field Safety Notice dated January 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Please do not use the dose reconstruction function COMPASS 3.1 and 3.1a for DMLC plans from Monaco or Eclipse -11 when the jaws move or MLC leaves reverse during beam on. A correct Version ( COMPASS 3.1b) will be delivered as soon as it is available. The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on February 2, 2015. Should you have questions or require additional information, please contact the Customer Service Team at South and Middle America, USA and Canada - Phone. +1 901.386.2246 Asia Pacific, Australia and New Zealand - Phone. +86 10 8080 9107 All other countries - Phone. 49 9128 607 - 38

Device

Device Recall COMPASS SW Version 3.1, Catalog Number CS10100
  • Modèle / numéro de série
    Model : SW Version 3.1  Lot or Serial Number : n.a
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and South America, Mexico, Brazil, Venezuela, Colombia, Panama, Asia, China, Japan, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, Malaysia and Guam.
  • Description du dispositif
    COMPASS SW Version 3.1, 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