Events

Retiro De Equipo (Recall) de ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery). 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-2015-RN-00805-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-27
  • 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-2015-RN-00805-1
  • 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
    Radiometer has recently become aware of a potential issue where a battery module had overheated caused by the continued charging of a collapsed battery cell. they have identified that worn battery modules with limited or no capacity manufactured in production runs below 910-311p0009nxxx are prone to cell collapses.
  • Acción
    Radiometer is advising users that battery modules below 910-311P0009Nxxx will be replaced with a newly designed battery module. Radiometer is advising users with battery modules 910-311P0009Nxxx and above will be required to undertake 12 monthly checks of the capacity of the battery modules. This action has been closed-out on 11/08/2016.

Device

ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery). An...
  • Modelo / Serial
    ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery). An in vitro diagnostic medical device (IVD)Battery modules: below 910-311P0009NxxxAll serial numbers affectedARTG Number: 228382
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd