Events

Retiro De Equipo (Recall) de 1.5T SIGNA HDX 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
    Recall
  • ID del evento
    32599
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-04-25
  • 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
    The screen save images are included in a wrong exam due to duplicate uid (unique identifier) creation. this may cause a safety issue due to a potential patient data mismatch.This issue occurs when all of the following criteria are met: performed procedure step (pps) is enabledtwo screen save series generated on study instanceuid starting with 1.X and 2.X respectively with pps status set as "defer" for both if these series are transferred to a cpsi pacs both of them would show up under the same patient study instanceuid starting with 1.X.

Device

1.5T SIGNA HDX MR SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: M3335J (Lot serial: ); Model Catalog: M3335JA (Lot serial: ); Model Catalog: M3335JB (Lot serial: ); Model Catalog: M3335JG (Lot serial: ); Model Catalog: M3000TD (Lot serial: ); Model Catalog: M3335AG (Lot serial: ); Model Catalog: M3335JK (Lot serial: ); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: ); Model Catalog: M1060LG (Lot serial: ALL); Model Catalog: M3000CB (Lot serial: )
  • Descripción del producto
    1.5T Signa HDX MR System
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)