Events

Retiro De Equipo (Recall) de Device Recall RayStation

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 RAYSEARCH LABORATORIES AB.

¿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
    74750
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0079-2017
  • Fecha de inicio del evento
    2016-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148383
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • Causa
    For a treatment plan consisting of multiple beam sets, the table for roi plan dose statistics in the report may show the statistics for a beam set dose. the error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.
  • Acción
    On May 19th, 2016, RaySearch Laboratories distributed Field Safety Notice, Medical Device Correction notices and reply forms to their customers via email. Actions to be taken by the customer include: 1) Inspect all report templates that are intended to be used for plans with multiple beam sets. 2) Make sure that POI Dose statistics (Plan) is included immediately before ROI Dose statistics [Plan dose] in the Report content area. 3) Please educate planning staff and all users about this workaround. 4) Inspect your product and identify all installed units with the above software version number. Finally, complete and return the reply form via email to: freddie.cardel@raysearchlabs.com or by fax to: 888-501-7195 to confirm that you have read and understand the information. Customers with questions can contact David Hedfors via email: david.hedfors@raysearchlabs.com

Device

Device Recall RayStation
  • Modelo / Serial
    5.0.0.37, 5.0.1.11 and 5.0.2.35
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AZ, CA, FL, MT, NC NY, TX, OH & WA
  • Descripción del producto
    Radiation Therapy Treatment Planning System, Model 5.0
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB