Events

Retiro De Equipo (Recall) de 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
    75173
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0038-2017
  • Fecha de inicio del evento
    2016-09-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149543
  • 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
    Raysearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. the correction concerns two issues found with the dose calculation when using a region of interest (roi) of type fixation or support with material override within the patient outline (external roi) in raystation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (inversearc 1.0).
  • Acción
    RaySearch sent a Field Safety Notice, on September 1, 2016, (RSL-D-61-301, dated 9/5/2016), was sent by e-mail to all affected customers. ACTIONS TO BE TAKEN BY THE USER Do not use ROIs of type Fixation or Support within the patient outline. Always use other ROI types for material override within the External ROI. A small overlap with the External ROI is acceptable if the Fixation or Support ROI is mainly outside the External ROI. Please educate planning staff and all users about this workaround. Inspect your product and identify all installed units with the above software version number, then confirm you have read and understood this notice (contact information below). SOLUTION A correction of these issues will be available in the next version of RayStation, scheduled for market release in December 2016. In the meantime, this field safety notice is distributed to all customers. Until a corrected version has been installed, all affected users must maintain awareness of this field safety notice. TRANSMISSION OF THIS FIELD SAFETY NOTICE This notice needs to be passed on to all those who need to be aware within your organization. Please maintain awareness of this notice as long as this version of RayStation is in use to ensure effectiveness of the workaround.

Device

RayStation
  • Modelo / Serial
    Build Numbers: 2.5.0.144, 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.42, 4.3.0.14, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11 or 5.0.2.35.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution
  • Descripción del producto
    RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System || RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB