Events

Retiro De Equipo (Recall) de ECLIPSE SMART SEGMENTATION

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por VARIAN MEDICAL SYSTEMS INC..

¿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
    84776
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-01-12
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    In affected eclipse versions user editing of mlc leaf positions may not automatically invalidate calculated dose distributions. eclipse calculates dose for each field in a treatment plan and when all fields are calculated dose is summed and displayed to the user. if a treatment plan has been saved then reloaded from the database for additional planning activities user repositioning of mlc leaves may not invalidate or "clear" the calculated field dose. this condition is a result of how items are loaded into memory and subsequently handled for efficiency memory use when fields and mlc are saved and then recalled from database system defaults specify that objects may be unloaded from memory if 90% of available resources are consumed or as a periodic system maintenance task when the application is open for longer than 12 hours. in the rare instance that an mlc "object" is unloaded from memory due to one of these conditions the dose for that field will nolonger be conditional to the state of the mlc. in this case a change in the mlc leaf positions would not cause the field dose to be invalidated. this may go unnoticed if another field in the plan is not calculated and the total dose is not currently dislayed to the user.

Device

ECLIPSE SMART SEGMENTATION
  • Modelo / Serial
    Model Catalog: TPA001094000 (Lot serial: H484528); Model Catalog: TPA001094000 (Lot serial: H487407); Model Catalog: TPA001094000 (Lot serial: H487506); Model Catalog: TPA001094000 (Lot serial: H484527); Model Catalog: TPA001094000 (Lot serial: H484530); Model Catalog: UP9001 (Lot serial: >10 Serial Numbers.); Model Catalog: UP9001 (Lot serial: Contact manufacturer.); Model Catalog: TPA001094000 (Lot serial: H484531); Model Catalog: TPA001094000 (Lot serial: H484526); Model Catalog: 100042024 (Lot serial: >10 Serial numbers.); Model Catalog: 100042024 (Lot serial: Contact manufacturer.); Model Catalog: TPA001075000 (Lot serial: >10 Serial numbers.); Model Catalog: TPA001075000 (Lot serial: Contact manufacturer.)
  • Descripción del producto
    ECLIPSE SMART SEGMENTATION
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.