Events

Retiro De Equipo (Recall) de OPTI R BLOOD GAS ANALYZER - INSTRUMENT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHOENIX AIRMID BIOMEDICAL CORP..

¿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
    138457
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-04-23
  • 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
    Opti medical investigated a report from the field where an opti cca-ts2 was found to measure thb high in whole blood. internal investigation has reproduced this finding showing a positive bias in thb results in whole blood when saturated oxygen (so2) is low. this issue was found on all opti blood gas analyzers manufactured after july 2009.

Device

OPTI R BLOOD GAS ANALYZER - INSTRUMENT
  • Modelo / Serial
    Model Catalog: GD7031 (Lot serial: 1334 and higher); Model Catalog: GD7013 (Lot serial: 2700 and higher); Model Catalog: GD7045 (Lot serial: GD7045 - 8056 and higher); Model Catalog: GD7046 (Lot serial: GD7045 - 8056 and higher); Model Catalog: GD7046 (Lot serial: GD7046 - All); Model Catalog: GD7045 (Lot serial: GD7046 - All)
  • Descripción del producto
    OPTI R ANALYZER
  • Manufacturer
    PHOENIX AIRMID BIOMEDICAL CORP.

Manufacturer

PHOENIX AIRMID BIOMEDICAL CORP.