Events

Rappel de Device Recall ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems

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
    59107
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2977-2011
  • Date de mise en oeuvre de l'événement
    2011-06-03
  • Date de publication de l'événement
    2011-08-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101206
  • 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
    A potential safety rick related to transferring reference images for offset calculation between a syngo rt therapist v 4.2 or a syngo rt oncologist 4.2 and other versions of the coherence/syn go rt therapist or oncologist or vice versa. an incorrect offset may be applied for patient positioning and result in dose being delivered to the wrong location.
  • Action
    Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION/CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 3, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides preventive measure instructions for customers to use until an update for the system is available.

Device

Device Recall ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems
  • Modèle / numéro de série
    The ARTISTE RT Therapist v4.2 and Oncologist v4.2 is used on the following: syngo RT Oncologist Part # 10652131; Therapist Express Basic, Part # 08151289; syngo RT Therapist, Part # 08162815; syngo RT Therapist Connect / MOSAIQ OSI, part # 08168754.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, FL, NC, NY, OH, PA, SD, UT, and WI and countries of Australia, Belgium, Croatia, Czech Republic, Germany, India, Ireland, Japan, Poland, Saudi Arabia, South Africa, Spain, Sweden, and United Kingdom.
  • Description du dispositif
    ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems. || Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany. || Delivery of 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