Retiro De Equipo (Recall) de SIGNA HDXT 1.5T MR SYSTEM - MAIN UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    For clariview and screen save from gvtk (gems visualization toolkit) viewer the mr product can generate image headers with nonunique series identifiers which when exported to some pacs systems results in the series being associated with the incorrect study on the pacs. the intended study will not have the correct series listed and an unintended study will have it listed instead. in all cases patient identifying annotation remains correct. the issue may result in an incorrect diagnosis from the study with mixed patient data if the series protocol and anatomy on the studies are similar and the annotation is not noticed. the conditions under which the issue is known to be possible require that the studies have identical time of day (identical hours minutes and seconds) and that the exams be on an affected model of pacs at the same time. this is possible with one scanner on different days or on different scanners on the same day.


  • Modelo / Serial
    Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: 00000287469MR1); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: 00000284254MR0); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: 00000304797MR4); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: 00002UA2400LWN)
  • Descripción del producto
  • Manufacturer