Events

Rappel de Device Recall RayStation Therapy Treatment Planning System

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 RAYSEARCH LABORATORIES AB.

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
    65136
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1419-2013
  • Date de mise en oeuvre de l'événement
    2013-02-15
  • Date de publication de l'événement
    2013-05-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117984
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • Cause
    Under some circumstances, imported ct, mr and pet images are offset from their true positions by one pixel in one or two directions. users must be aware of this information to avoid incorrect dose calculations during treatment planning.
  • Action
    RaySearch Laboratories sent an Urgent Field Safety Notice, Medical Device Correction letter dated January 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to educate their planning staff and all users about the recommended workarounds contained in the letter. Customers were also asked to inspect their product and identify all installed units that were infected and then complete the attached Reply Form and e-mail or scan a copy of the completed form to the firm. Customers were instructed to pass along this information to all those who need to be aware of this Medical Device Correction Customers with questions were instructed to contact the RaySearch support email at support@raysearchlabs. For questions regarding this recall call +46 8 545 06130.

Device

Device Recall RayStation Therapy Treatment Planning System
  • Modèle / numéro de série
    Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.
  • Description du dispositif
    RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. || RayStation is a software system designed for treatment planning and analysis of radiation therapy.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB