Events

Rappel de 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
    60409
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0359-2012
  • Date de mise en oeuvre de l'événement
    2011-10-19
  • Date de publication de l'événement
    2011-12-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105264
  • 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
    The firm has found an issue with dicom rt image representation of drr images from raystation 2.0 which needs to be clarified in the user manual. the symptoms involve the pixel spacing and image position attributes in the rt images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient.
  • Action
    The firm, RaySearch Laboratories, sent an email with an "Urgent Field Safety Notice Medical Device Correction" notice dated October 19, 2011 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to pass on the information in the field safety notice to everyone involved and create routines to compensate for the incorrect DRR images; if the DICOM DRR images are not used to make any form of absolute measurements, no action needs to be taken. Raysearch laboratories will provide a script to update these DICOM files to have the correct values upon request. For further information please contact RaySearch Laboratories AB Quality and Regulatory Affairs Manager at +46 722 366 110 or david.hedfors@raysearchlabs.com; RaySearch Americas Director of Customer Support at +1 877 778 3489 or freddie.cardell@raysearchlabs.com.

Device

RayStation
  • Modèle / numéro de série
    Software version and build number is 2.0.0.15
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: MA, NJ, and NY; and country of: Netherlands
  • Description du dispositif
    RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com || RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB