Events

Rappel de Device Recall MOSAIQ 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
    61308
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1270-2012
  • Date de mise en oeuvre de l'événement
    2012-02-14
  • Date de publication de l'événement
    2012-03-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107779
  • 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
    Images used in treatment planning may belong to another patient. risk of treatment to wrong area. software update to upgrade siemens installed base to the latest release of mosaiq version 2.00x3 sp5, for rt therapist version 2.1a.
  • Action
    Siemens sent a Customer Information letters to all affected customers. The Customer information letters inform customers of the release of MOSAIQ 2.00X3 SP5 which specifically addresses a safety issue that is only found when MOSAIQ is used with COHERENCE Therapist 2.1 MQ (also called RTT2.1A). This letter is to be kept with Customer information documentation. Update Instruction TH004/12S are being issued with the update. The Software update is delivered and installed by qualified Field Service Engineers. For questions, contact your responsible SIEMENS Service Engineer or Application Specialist.

Device

Device Recall MOSAIQ System;
  • Modèle / numéro de série
    MOSIAQ System model number 10568605.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of KY, PA, TN, WI, and P.R. and the countries of Australia, Belgium, Bosnia Herzeg. China, Colombia, Croatia, Czech Republic, Germany, India, Ireland, Japan, Lebanon, Malaysia, Mexico, New Zealand, Philippines, Poland, Russian Federation, South Africa, Saudi Arabia, Thailand, Turkey, and United Kingdom.
  • Description du dispositif
    MOSAIQ System; || customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. || MOSAIQ Oncology information system is owned and marketed by IMPAC Medical System, Inc. MOSAIQ is distributed by Siemens Medical Solutions USA, Inc, Radiation Oncology under a distributor contract with IMPAC Medical. || Distributed by Siemens Healthcare, Concord, Ca. || Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and ARTISTE Solution family of linear accelerators systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. || P
  • 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