Events

Retiro De Equipo (Recall) de Device Recall Blood Gas and CoOx Electrolyte & Metabolyte Analyzer.

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Radiometer America Inc.

¿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
    34953
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1318-06
  • Fecha de inicio del evento
    2005-06-17
  • Fecha de publicación del evento
    2006-08-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45004
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    blood gas analyzer - Product Code CHL
  • Causa
    Software defect. po2 and pco2 sample test results run on the firm's abl700/800 series blood gas analyzers are not being properly flagged during the sample calibration phase.
  • Acción
    The customers were apprised of this situation with a recall letter issued by the firm on 6/17/2005. In addition, new Operators Manuals were sent to the customers. In the letter, the customers were advised that a Service Engineer would be contacting them shortly in order to arrange for the installation of the software upgrade. The firm''s Service Engineers visited each customer location and installed software upgrades. Version 3.831 software was installed on the 700 Series Analyzers and Version 4.14 was installed on the 800 Series Analyzers. According to the firm, these software corrections were verified as having been completed by 3/10/2006.

Device

Device Recall Blood Gas and CoOx Electrolyte & Metabolyte Analyzer.
  • Modelo / Serial
    All analyzers manufactured from 1/2005-10/31/2005. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Dirección del fabricante
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA