Events

Rappel de ARTISTE, ONCOR, MEVATRON, and PRIMUS 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, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510.

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
    56773
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0907-2011
  • Date de mise en oeuvre de l'événement
    2010-08-13
  • Date de publication de l'événement
    2011-01-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94518
  • 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
    Linear Medical Accelerator - Product Code IYE
  • Cause
    The potential safety issue with the 160mlc or the hpd collimator of mechanical noises and/or sticking of the collimator when rotating the collimator. the potential for mistreatment to a patient should the collimator not be aligned correctly if the bearings are damaged.
  • Action
    Urgent: Medical Device Correction Safety Advisory Notice letters were sent by certified mail commencing August 3, 2010. The letter described the issue and when it occurs, the measures users could take, and how Siemens would address the issue. It is recommended that customers include a check of the field alignment at 90 and 270 degrees gantry angle in the daily check prior to start of patient treatments. A copy of the Safety Advisory Notice should be included in the Owner's Manual and questions should be directed towards the local Siemens Service Engineer or Application Specialist.

Device

ARTISTE, ONCOR, MEVATRON, and PRIMUS Digital Linear Accelerators
  • Modèle / numéro de série
    All units of these models.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    ARTISTE and ONCOR Digital Linear Accelerators configured with the 160 leaf Multi-Leaf Collimator (MLC) and MEVATRON and PRIMUS Digital Linear Accelerators configured with the High Performance Defining Collimator (HPD); Product is manufactured by Kemnath, Germany-Siemens AG OCS and Siemens AG, Erlangen, Germany-Siemens AG OCS and distributed by Siemens Medical Solutions, Oncology Care Systems, Concord, CA; || Intended to deliver x-ray radiation for therapeutic treatment of cancer. || ARTISTE with 160 MLC, Part No.8139789, || ONCOR AG with 160 MLC, Part No.5863472 || ONCOR Impression || Plus with 160 MLC, Part No.5857912, || ONCOR Expression with 160 MLC, Part No.7360204, || ONCOR Expression with 160 MLC, Part No.7360717, || PRIMUS HI with HPD, Part No. 4504200, || MEVATRON M2 / PRIMUS Mid-Energy / HPD, Part No.1940035, || MEVATRON 6323-2 / HPD, Part No.19244500, || MEVATRON K2 / HPD, Part No.1940753, || MEVATRON PRIMART / HPD, Part No.5500371, || MEVATRON 77 / HPD, Part No.5659503, || MEVATRON M 7400 / 7440 (MEX) / HPD, Part No.5672977, || MEVATRON M 6700 (MX) / HPD, Part No.5693908, || MEVATRON M 6730 / HPD, Part No.5694005, || MEVATRON M 7140 / HPD, Part No.5694104, || MEVATRON M 7400 / HPD, Part No.5694153, || MEVATRON M 7445 / HPD (MEX), Part No.5694203, || MEVATRON K 7467 / HPD, Part No.5694252, || MEVATRON K 7767 / HPD, Part No.5694302, || MEVATRON K 8067 / HPD, Part No.5694401, || MEVATRON M 6300 (MX) / HPD, Part No.8317000, || MEVATRON M 6730/6740 (MEX) / HPD, Part No.8319758, || MEVATRON MD (MD, MDX) / HPD, Part No.8319808, || MEVATRON KD / HPD, Part No.8319857, || MEVATRON MDX / HPD, Part No.8496200, || MEVATRON KD-2 / HPD, Part No.8515520, || MEVATRON M3 6300 / HPD, Part No.9401316, || MEVATRON M2 6700 / HPD, Part No.9401407, || MEVATRON M2 6740 / HPD, Part No.9401506, || MEVATRON KDS / HPD, Part No.941522, || MEVATRON MD-2 / HPD, Part No.9401654, || MEVATRON MDX  2 / HPD, Part No.9401746, || MEVATRON KDS-2 / HPD, Part No.9411588, || MEVATRON KD-2 / HPD, Part No.9822685, || MEVATRON KDS-2 / HPD, Part No.9822693
  • Manufacturer
    Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510

Manufacturer

Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510
  • Adresse du fabricant
    Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510, 4040 Nelson Ave, Concord CA 94520-1200
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA