Events

Retiro De Equipo (Recall) de APEXPRO TELEMETRY SYSTEM - CLINICAL INFORMATION CENTRE

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
    108304
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-04-29
  • 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
    Operator's manual does not warn against the unintended use of apexpro telemetry to monitor spo2 without concurrent ecg monitoring & does not identify correct alarms & messages during loss of spo2 data condition.

Device

APEXPRO TELEMETRY SYSTEM - CLINICAL INFORMATION CENTRE
  • Modelo / Serial
    Model Catalog: CICV3APRO=XXX/XXX (Lot serial: MANUFACTURER); Model Catalog: CICV3APRO=XXX (Lot serial: MANUFACTURER); Model Catalog: APRSRVR16=XXX (Lot serial: MANUFACTURER); Model Catalog: 418779-010 (Lot serial: CONTACT); Model Catalog: CICV4APRO=XXX (Lot serial: CONTACT); Model Catalog: CICV3APRO=XXX/XXX (Lot serial: CONTACT); Model Catalog: CICV3APRO=XXX (Lot serial: CONTACT); Model Catalog: APRSRVR16=XXX (Lot serial: CONTACT); Model Catalog: 418779-010 (Lot serial: >100 NUMBERS); Model Catalog: CICV4APRO=XXX (Lot serial: >100 NUMBERS); Model Catalog: CICV3APRO=XXX/XXX (Lot serial: >100 NUMBERS); Model Catalog: CICV3APRO=XXX (Lot serial: >100 NUMBERS); Model Catalog: APRSRVR16=XXX (Lot serial: >100 NUMBERS); Model Catalog: 418779-010 (Lot serial: MANUFACTURER); Model Catalog: CICV4APRO=XXX (Lot serial: MANUFACTURER)
  • Descripción del producto
    APEXPRO TELEMETRY SUSTEM- CLINICAL INFO
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)