Events

Retiro De Equipo (Recall) de APEXPRO TELEMETRY 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
    119416
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-08-26
  • 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
    Potential loss of patient monitoring when apexpro telemetry system is used with a "mirrowed" view carescape cic pro in combination monitoring mode which may result in delay of treatment of a cardiac event.

Device

APEXPRO TELEMETRY SYSTEM
  • Modelo / Serial
    Model Catalog: APROT1-XX-XXX-XXX-X (Lot serial: S/N'S A1GQ0243G B1GQ0333G); Model Catalog: APROT1-XX-XXX-XXX-X (Lot serial: M0GQ0133G M0GQ0139G); Model Catalog: APROT1-XX-XXX-XXX-X (Lot serial: C1GQ0377G F1GQ0696G); Model Catalog: CIC3APRO=XXX (Lot serial: L34T4067G); Model Catalog: CICV4APRO=X (Lot serial: L34T4067G); Model Catalog: CICV4APRO=X (Lot serial: S/N'S AA104220209GA); Model Catalog: CICV4APRO=X (Lot serial: AA104260532GA D34T2533G); Model Catalog: CIC3APRO=XXX (Lot serial: S/N'S AA104220209GA); Model Catalog: CIC3APRO=XXX (Lot serial: AA104260532GA D34T2533G); Model Catalog: CARESCAPE TELEMETRY SERVER (Lot serial: MANUFACTURER); Model Catalog: APRSRVR16=XXX (Lot serial: >10 NUMBERS); Model Catalog: CARESCAPE TELEMETRY SERVER (Lot serial: >10 NUMBERS); Model Catalog: APRSRVR16=XXX (Lot serial: CONTACT); Model Catalog: CARESCAPE TELEMETRY SERVER (Lot serial: CONTACT); Model Catalog: APRSRVR16=XXX (Lot serial: MANUFACTURER)
  • Descripción del producto
    APEXPRO TELEMETRY SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)