Events

Retiro De Equipo (Recall) de ADVANTX LCLP+ BI PLANE CARDIAC SYSTEM

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
    15935
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-07-31
  • 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 lcd monitor support may disengage from its arm and fall on the table. incorrect cable routing may cause the ecg monitor power cable to be damaged. potential for short circuit sparks & electric shock.

Device

ADVANTX LCLP+ BI PLANE CARDIAC SYSTEM
  • Modelo / Serial
    Model Catalog: 2168678-3 (Lot serial: 208/60218 704/20006); Model Catalog: 2124818 (Lot serial: 1103/00001); Model Catalog: S1838JK (Lot serial: 1203/00008 0304/10063); Model Catalog: S1838JK (Lot serial: 00000452849BU300000524113BU8); Model Catalog: 2124818 (Lot serial: S/N 704/20021 504/10005); Model Catalog: S18741AM (Lot serial: 0604/20097 1203/00031); Model Catalog: S18741AM (Lot serial: 00000112438VE7 00000460566BU3); Model Catalog: S18741AM (Lot serial: 1203/00030 1203/00034); Model Catalog: S18741AM (Lot serial: 0304/10068 00000469393BU3); Model Catalog: S18741AM (Lot serial: 304110070 00000536832BU1); Model Catalog: S18751AM (Lot serial: 1207/60204 507/50957); Model Catalog: S18751AM (Lot serial: 1007/61039 00000524145BU0); Model Catalog: S18751AM (Lot serial: 1007/61038 1005/40433); Model Catalog: S18751AM (Lot serial: 1005/40435); Model Catalog: S18751AM (Lot serial: 00000452927BU7 907/6010)
  • Descripción del producto
    ADVANTIX LCLP+ BI PLANE CARDIAC SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)