Events

Rappel de Siemens

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
    61578
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1494-2012
  • Date de mise en oeuvre de l'événement
    2012-04-04
  • Date de publication de l'événement
    2012-05-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108458
  • 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
    The firm became aware of a potential issue with siemens-branded oncor or primus linear accelerator with an optivue or mvision imaging system that has the potential collision problem of the imaging panel if the panel does not retract before the gantry rotates; this may result in patient injury.
  • Action
    Siemens sent an Update Instruction containing the Customer Information letters beginning April 4, 2012 delivered by Siemens customer Service Group or by certified mail to all affected customers. The letter identified the affected product, what is the issue and what has Siemens done to address this issue. The letter instructs customer to include this Customer Information in their Digital Linear Accelerator System Owner Manual chapter Safety Advisory Letters where it should remain.

Device

Siemens
  • Modèle / numéro de série
    All units of these models.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Description du dispositif
    Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system; || Model Numbers: ONCOR Expression 7360717, ONCOR Impression Plus 5857912, ONCOR Avant Garde 5863472, PRIMUS HI 4504200; || ARTISTE/ONCOR/PRIMUS systems are manufactured by: || SIEMENS AG, MEDICAL SOLUTIONS, || Roentgenstrasse 19-21, || Kemnath, GERMANY 95478 || Product Usage: || Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems 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