Events

Retiro De Equipo (Recall) de Device Recall MRIdian ViewRay Radiation Therapy System, ViewRay

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Viewray Incorporated.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    72166
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0115-2016
  • Fecha de inicio del evento
    2015-08-27
  • Fecha de publicación del evento
    2015-10-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140076
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, radiation therapy, radionuclide - Product Code IYE
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
  • Descripción del producto
    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
  • Dirección del fabricante
    Viewray Incorporated, 2 Thermo Fisher Way, Oakwood Village OH 44146-6536
  • Empresa matriz del fabricante (2017)
    ViewRay, Inc.
  • Source
    USFDA