Events

Rappel de TrueBeam and TrueBeam STx,

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 Varian Medical Systems, Inc. Oncology Systems.

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
    60411
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0364-2012
  • Date de mise en oeuvre de l'événement
    2011-10-31
  • Date de publication de l'événement
    2011-12-02
  • 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=105265
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notes supplémentaires dans les données
    Accelerator, linear, medical - Product Code -IYE
  • Cause
    An anomaly has been identified with the truebeam and truebeam stx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape.
  • Action
    On 11/04/2011, an Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps. Varian is developing a corrective action for this issue. A customer service representative will contact you when the correction is available to schedule installation on your system. Questions regarding the letter should be directed to the Varian Oncology Help Desk Contact Information at USA and Canada: 1-888-827- 4265 or Europe +41-41-749-8844.

Device

TrueBeam and TrueBeam STx,
  • Modèle / numéro de série
    Model numbers: H191113, H191034, H191105, H191154, H191046, H191053, H191044, H191015, H191035, H191108, 191152, H191140, H191069, H191017, H191027, H191109, 191130, H191002, H191071, H191024, H191078, H191111, 191072, H191102, H191074, H191087, H191151, H191125, 191018, H191058, H191038, H191115, H191085, H191032, 191077, H191023, H191103, H191095, H191163, H191146, 191124, H191138, H191093, H191097, H191040, H191030, 191029, H191060, H191066, H191122, H191054, H191126, 191114, H191082, H191067, H191081, H191005, H191013, 191116, H191051, H191094, H191052, H191031, H191021, 191048, H191139, H191099, H191020, H191039, H191128, 191156, H191057, H191061, H191112, H191049, H191083, 191008, H191123, H191065, H191119, H191089, H191120, 191092, H191134, H191129, H191056, H191090, H191033, 191047, H191037, H191076, H191007, H191028, H191080, 191106, H191118, H191073, H191117, H191155, H191086, 191141, H191025, H191036, H191042, H191079, H191135, 191010, H191100, H191107, H191127, H191063, H191070, 191153, H191026, H191096, H191014, H191064, H191059, 191009, H191142, H191068, H191001, H191132, H191011, 191003, H191136, H191022, H191121, H191016, H191012, 191045, H191101, H191088, H191041, H191043, H191150, 191019, H191055, H191133, H191131, H191091, H191098, 191006 and H191110
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution including the US and Internationally.
  • Description du dispositif
    TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Adresse du fabricant
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Société-mère du fabricant (2017)
    Varian Medical Systems Inc
  • Source
    USFDA