Events

Retiro De Equipo (Recall) de RaySearch_Radiation therapy treatment planning system

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand 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
    22552
  • Fecha de inicio del evento
    2018-02-02
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: CARSL Consulting, 50B Puketapu Road, Taradale, Napier 4112
  • Causa
    An issue found with the center beam in field functionality in raystation 4.9 (rayplan 1), raystation 5, raystation 6 (rayplan 2) and raystation 7 (rayplan 7). when more than one beam is defined on the same isocenter, center beam in field (cbf) affects all beams in a way that the user may not expect. after using cbf, the resulting fields are clearly displayed in raystation/rayplan for review and approval.
  • Acción
    Software to be upgraded

Device

RaySearch_Radiation therapy treatment planning system
  • Modelo / Serial
    Model: RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7), Affected:
  • Manufacturer
    RaySearch Laboratories AB

Manufacturer

RaySearch Laboratories AB