Events

Retiro De Equipo (Recall) de Radiometer ABL90 Series analysers with software version 3.2 or below. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Radiometer Pacific Pty Ltd.

¿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
    RC-2017-RN-00714-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-07
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00714-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    In august 2015 radiometer advised users about a potential issue (tga ref. rc-2015-rn-00805-1) where a battery module overheated caused by the continued charging of a failing battery cell. the temporary countermeasure recommended, after the battery modules below 910-311p0009nxxx had been replaced, was for the capacity of the battery module to be checked at least every 12 months following the instructions that were provided.The manufacturer has now released an upgrade of the abl90 series software to software version 3.3 or higher. this new version monitors the charge level for the battery. if one or more failing battery cells are detected, the analyser status turns yellow and message 1559 “battery error detected” appears. if message 1559 has been active for four weeks in a row, the analyser enters operator intervention required with message 1560 “battery error still detected” and the analyser is locked until the battery has either been removed or exchanged.
  • Acción
    Radiometer will contact users to arrange for the installation of the software upgrade.

Device

Radiometer ABL90 Series analysers with software version 3.2 or below. An in vitro diagnostic medi...
  • Modelo / Serial
    Radiometer ABL90 Series analysers with software version 3.2 or below. An in vitro diagnostic medical device (IVD)All Serial NumbersARTG Number: 228382
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd