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
    61580
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1493-2012
  • Date de mise en oeuvre de l'événement
    2012-04-03
  • Date de publication de l'événement
    2012-05-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108483
  • 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 (issue 1). additionally, there may be a potential for collision if the operator does not ensure clearance of the extended flat panel positioner for all gantry rotation angles (issue 2).
  • Action
    Siemens sent a Safety Advisory Notice with Update to all affected customers. The notice informed the customers of the risk of pressing the Motion Stop button repeatedly during treatment. Work Steps were provided for customers to follow.

Device

ARTISTE or ONCOR Linear Accelerators in combination with 160MLC
  • Modèle / numéro de série
    Product Model with Part Number: ARTISTE MV System, 8139789; ONCOR Avant Garde, 5863472; ONCOR Impression, 5857920; ONCOR Impression, Plus 5857912; ONCOR Expression, 7360204; ONCOR Expression, 7360717
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including the states of 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. || Product Model with Part Number: || ARTISTE MV System, 8139789; || ONCOR Avant Garde, 5863472; || ONCOR Impression, 5857920; || ONCOR Impression, Plus 5857912; || ONCOR Expression, 7360204; || ONCOR Expression, 7360717. || 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