Events

Rappel de Device Recall RaySearch RayStation 4.7

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
    71414
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2457-2015
  • Date de mise en oeuvre de l'événement
    2015-05-27
  • Date de publication de l'événement
    2015-08-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-09-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137704
  • 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
    Issue with the algorithm for roi contraction in raystation 4.7 when non-uniform contraction distances are used. the roi contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. these contraction distances are, in error, pairwise reversed, i.E. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.
  • Action
    On May 27, 2015 RaySearch Laboratories distributed Medical Device Correction notices to their customers via courier service. Within the Medical Device Correction notice, RaySearch Laboratories included a workaround to the problem for their customers. Customers should not use structure templates containing derived ROI definitions with non-uniform contractions. They should avoid using non-uniform contractions. In the case non-uniform contractions must be used, enter switched distances manually and review the result carefully before using it for treatment planning. Lastly, do not use humerus shielding in Automatic Breast Planning. Customers are also expected to complete and return the lower portion of the correction notice via fax to 888-501-7195. **CAPA** Correct the software problem in patch version 4.7.2 of RayStation 4.7, scheduled for market release June 2015.

Device

Device Recall RaySearch RayStation 4.7
  • Modèle / numéro de série
    software build numbers are 4.7.1.10
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in CO, IL, MI, NC, OH,TN, and WA.
  • Description du dispositif
    RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB