Events

Rappel de Device Recall RayAutoplan, aka tRayAutoplan, commercial name (TomoTherapy) SharePlan

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
    63110
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2378-2012
  • Date de mise en oeuvre de l'événement
    2011-05-30
  • Date de publication de l'événement
    2012-09-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112573
  • 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 field notice concerns two behaviors of the shareplan (multiple fraction groups and depth offset) that may be unexpected and are not clearly described in the user manual. none of these behaviors have 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 delivere.
  • Action
    RaySearch Laboratories sent an Urgent Field Safety Notice Medical Device Correction dated May 30, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consigness were instructed to completely avoid affecting the erroneous behaviour, verify in TomoTherapy Hi-Art that the plans sent to TomoTherapy SharePlan 1.1 only have one single fraction group with a single fraction size,used for all fractions, and do not attempt to import treatment plans having more than one fraction size into the product. To completed avoid affecting the erroneous behaviour the user can either offset the measured curves before importing them into beam commissioning or add the depth offset tothe calibration depth. For further information consigness should contact RaySearch Laboratories AB Quality and Regulatory Affairs at +46 722 366 110 or the Tomo Therapy support at support@tomotherapy.com. North America 1 866 368 4807 Belgium 0800 38783 France 0805 631 565 Germany 0800 000 +541 Italy 800-986 399 Netherlands 0800 0201364 Spain 800 3000049 Switzerland 0800 001927 UK 0868 238 6035 China/Northern 10 800 712 1701 China/Southern 10800 120 1701 Hong Kong 800 967912 Japan 0044 22 132374 Singapore 800 1204683 South Korea 0079 81 4800 7204 All other locations + 1 608 824 2900 or +32 2 40 44 44

Device

Device Recall RayAutoplan, aka tRayAutoplan, commercial name (TomoTherapy) SharePlan
  • Modèle / numéro de série
    SharePlan 1.1, aka t-RayAutoplan 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, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland.
  • Description du dispositif
    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. || 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