Events

Rappel de Device Recall ARTISTE MV with Artiste Digital Linear Accelerators

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., Concord, CA.

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
    57704
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1422-2011
  • Date de mise en oeuvre de l'événement
    2010-12-03
  • Date de publication de l'événement
    2011-02-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97050
  • 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 become aware of a potential issue with artiste system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if the flat panel is over the patient.
  • Action
    The firm, Siemens, issued a "Customer Information" letter on December 3, 2010 via mail to all its direct consignees/customers. The letter described the product, problem and actions taken by the firm to the customer. Siemens arranged for an inspection of their customers systems to make sure the safety mechanism is fully functional. Siemens instructed the customers to include the Customer Information letter in their ARTISTE System Owner manual chapter 'Safety Advisory Letters' . If you any questions, please call 925-246-8407.

Device

Device Recall ARTISTE MV with Artiste Digital Linear Accelerators
  • Modèle / numéro de série
    Serial No. 5647 - 5718  (Specifically 5647,5651,5652,5660,5657, 5664,  5654,5686,5687,5688,5689, 5606,  5690,5700,5701,5699,5704,5705,5707,5708,  5714, 5716, and 5718)
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution.
  • Description du dispositif
    Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No. 8139789; || Intended use: To deliver x-ray radiation for therapeutic treatment of cancer. || Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA; and Siemens Medical Solutions AG, Roentgenstrasse, Kemnath, Germany, and Siemens Medical Solutions AG, Henkestrasse, Erlangen, Germany
  • Manufacturer
    Siemens Medical Solutions USA, Inc., Concord, CA

Manufacturer

Siemens Medical Solutions USA, Inc., Concord, CA
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc., Concord, CA, 4040 Nelson Ave, Concord CA 94520-1200
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA