Events

Rappel de Device Recall RayStation

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
    67504
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1307-2014
  • Date de mise en oeuvre de l'événement
    2014-02-06
  • Date de publication de l'événement
    2014-03-28
  • 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=125602
  • 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
    Potential for dose errors due to software program errors.
  • Action
    RaySearch Laboratories sent an Field Safety Notice, Medical Device Correction letter dated February 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. ACTIONS TO BE TAKEN BY THE USER A workaround that eliminates the described error is to select the discard rotations option in the Image Registration Module before creating a rigid registration intended to be used for hybrid deformable registration. Another option is to use the ROI based deformable registration when applicable, as this functionality is not affected by the error. SOLUTION This issue will be resolved in a patch release of RayStation, scheduled for market release February 28, 2014. Release schedule is subject to regulatory approval for some markets. In the meantime, this field safety notice is being distributed to all customers. CONTACT INFORMATION For further information, please contact For the Americas: Customer Support, RaySearch Americas, at +1 877 778 3849 For Europe, Asia and rest of the world: RaySearch Laboratories AB, at +46 8 5450 6130 Thank you for your cooperation, and we apologize for any inconvenience

Device

Device Recall RayStation
  • Modèle / numéro de série
    MODEL #(s): 2.5, 3.0, 3.5 and 4.0; VERSIONS: 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including the states of NY, OH, MD, CT, CO, TN, IL, AZ, MS, NJ, PA, DE, FL, CA and WA., and the countries of New Zealand, Australia, Republic of Korea, China, Italy, Germany, Norway, Belgium, Switzerland, United Kingdom and Spain.
  • Description du dispositif
    RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB