Events

Rappel de SharePlan 1.1

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
    63186
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2444-2012
  • Date de mise en oeuvre de l'événement
    2011-10-10
  • Date de publication de l'événement
    2012-09-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-01-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112869
  • 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
    This notice concerns behavior of the shareplan that may be unexpected and not clearly described in the user manual. this behavior has not caused patient mistreatment or other incidents. however, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. the behavior appears, when importing rfa-files (.Asc).
  • Action
    RaySearch Laboratories sent an Urgent Field Safety Notice Medical Device Correction letter dated October 10, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. To completely avoid effects of the erroneous behaviour, RFA-file has to be modified to have the crossline profiles sgtored in the X column of the file and the inline profiles in the Y column. Upon request, RaySearch Laboratories will provide help to the customers by transferring the RFA-files to the correct format through a scrip. Customers were instructed to pass on the notice to all those who need to be aware within their organization and to maintain awareness on this notice until the new labeling version has been received to ensure effectiveness of the corrective action. For questions regarding this recall call +46 8 54 50 61 42.

Device

SharePlan 1.1
  • Modèle / numéro de série
    version 1.2.1 (build number 1.3.1.10).
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom.
  • Description du dispositif
    SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan || Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB