Events

Rappel de Device Recall ARTISTE / RT Therapist v4.1 system

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 Siemens Medical Solutions USA, Inc.

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
    58517
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2190-2011
  • Date de mise en oeuvre de l'événement
    2011-03-24
  • Date de publication de l'événement
    2011-05-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99503
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Cause
    When using the artiste linac and rt therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment.
  • Action
    Distribution of the Urgent: Medical Device Correction Customer Advisory Notice began on March 24, 2011 via certified mail or by the Siemens Customer Service Group. The letter identified the issue and when it occurs. Users were asked to verify the isocenter position of the reference image in the Portal Review application before using a reference image imported from the treatment planning system. Siemens is currently working on a solution and will notify customers as soon as the update is available. The letter should be included with the Owner Manual of the system in the chapter for "Safety Advisory Letters" until an update is provided.

Device

Device Recall ARTISTE / RT Therapist v4.1 system
  • Modèle / numéro de série
    ARTIST Systems include: Therapist Express Basic Part number 08515289; Therapist Express Assist Part number 08515297; syngo RT Therapist Assist Part number 08162807; syngo RT Therapist Part number 08162815; and  sysno RT Therapist connect/MPSAOQ OIS Part number 08168754.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    ARTISTE / RT Therapist v4.1 system. || The ONCOR and PRIMUS system may be updated to utilize the RT Therapist v4.1 software. || Siemens Healthcare, Concord, CA. || The intended use is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA