Events

Rappel de ARTISTE or ONCOR Linear Accelerators in combination with 160MLC

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
    58637
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2404-2011
  • Date de mise en oeuvre de l'événement
    2011-04-15
  • Date de publication de l'événement
    2011-06-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99754
  • 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
    Siemens became aware of a potential safety risk related to the behavior of the 160 mlc when using the "motion stop" button followed by "reset" several times during the treatment of one beam or one segment.
  • Action
    Siemens sent a Consumer Safety Advisory and Urgent Medical Device Correction letter to all affected customers beginning on April 15, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Updated instructions for using the Motion Stop button with the 160-MLC were provided with the letter. Customers were requested to use the Motion Stop button and the corresponding reset procedure only when required. In the unlikely event that the Motion Stop button needs to be used repeatedly during treatment of the same beam or segment, customers were advised to perform an "in session resumption of the beam by selecting 'abort' at the syngo RT Therapist and then re-selecting the beam again for the remaining delivery. In this case, the beam will be re-loaded with the originally prescribed leaf positions. Please consider the already delivered dose for resumption. Customers were asked to include the Customer Advisory Notice in their LINAC System Owner Manual in chapter 'Safety Advisory Letters' where it should remain until the measures defined above were performed. Customers were asked to inform all affected personnel immediately.

Device

ARTISTE or ONCOR Linear Accelerators in combination with 160MLC
  • Modèle / numéro de série
    Product Model Number ARTISTE MV System 8139789 ONCOR Avant Garde 5863472  ONCOR Impression 5857920 ONCOR Impression Plus 5857912 ONCOR Expression 7360204 and 7360717
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, DE, FL, IL, KY, LA, MA, MI, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV.
  • Description du dispositif
    ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: || ARTISTE MV System; || ONCOR Avant Garde || ONCOR Impression || ONCOR Impression Plus || ONCOR Expression. || Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany; || Registered by Siemens Medical Solutions, Concord, CA. || ARTISTE and ONCOR family of Linear Accelerators are used 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