Events

Rappel de Device Recall MRIdian ViewRay Radiation Therapy System, ViewRay

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 Viewray Incorporated.

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
    72166
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0115-2016
  • Date de mise en oeuvre de l'événement
    2015-08-27
  • Date de publication de l'événement
    2015-10-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140076
  • 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
    System, radiation therapy, radionuclide - Product Code IYE
  • Cause
    Viewray discovered that in the event that an encoder breaks or fails on the patient handling system (phs, or couch), when attempting to restart the system, the couch could move unexpectedly.
  • Action
    ViewRay sent an Customer Advisory Notice dated August 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It is recommended that if you have a patient on the couch and you receive the fault ''The patient table has experienced an unintended movement. This may be due to the patient or operator leaning on the table. Clear the fault and retry. If the problem persists call Service" on the TPDS,first attempt to clear the fault. If it does not clear and requires you to restart the couch software (same switch as restarting the RTCS) you should manually remove the patient from the couch before restarting the system. A software patch to address this issue is planned for early 2016. In the meantime please practice our recommendation of removing the patient from the couch prior to restarting the RTCS. If you have any questions or concerns regarding this issue, please do not hesitate to contact ViewRay Customer Support at support@viewray.com or call the ViewRay¿¿ Customer Support center at 855-286-8875.

Device

Device Recall MRIdian ViewRay Radiation Therapy System, ViewRay
  • Modèle / numéro de série
    Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
  • Description du dispositif
    MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ || Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
  • Manufacturer
    Viewray Incorporated

Manufacturer

Viewray Incorporated
  • Adresse du fabricant
    Viewray Incorporated, 2 Thermo Fisher Way, Oakwood Village OH 44146-6536
  • Société-mère du fabricant (2017)
    ViewRay, Inc.
  • Source
    USFDA