Events

Retiro De Equipo (Recall) de Device Recall RayStation Therapy Treatment Planning System

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
    65136
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1419-2013
  • Fecha de inicio del evento
    2013-02-15
  • Fecha de publicación del evento
    2013-05-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117984
  • 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
    Under some circumstances, imported ct, mr and pet images are offset from their true positions by one pixel in one or two directions. users must be aware of this information to avoid incorrect dose calculations during treatment planning.
  • Acción
    RaySearch Laboratories sent an Urgent Field Safety Notice, Medical Device Correction letter dated January 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to educate their planning staff and all users about the recommended workarounds contained in the letter. Customers were also asked to inspect their product and identify all installed units that were infected and then complete the attached Reply Form and e-mail or scan a copy of the completed form to the firm. Customers were instructed to pass along this information to all those who need to be aware of this Medical Device Correction Customers with questions were instructed to contact the RaySearch support email at support@raysearchlabs. For questions regarding this recall call +46 8 545 06130.

Device

Device Recall RayStation Therapy Treatment Planning System
  • Modelo / Serial
    Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.
  • Descripción del producto
    RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. || RayStation is a software system designed for treatment planning and analysis of radiation therapy.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB