Events

Retiro De Equipo (Recall) de Radiometer TCM5FLEX/BASICAll

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-2018-RN-00297-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-04-13
  • 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-2018-RN-00297-1
  • 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 that the wi-fi hardware incorporated in the tcm5 monitor is not compliant with respect to the requirements for radiated emission (radio equipment directive 2014/53/eu).Australian customers do not currently utilise the wi-fi option on these devices.
  • Acción
    Radiometer is advising that they will be contacting affected users to arrange for the software to be upgraded on TCM5 to V1.2.0 which will disable the Wi-Fi hardware. Customers have been supplied an updated IFU which removes reference to Wi-Fi as part of the correction undertaken for RC-2018-RN-00299-1

Device

Radiometer TCM5FLEX/BASICAll
  • Modelo / Serial
    Radiometer TCM5FLEX/BASICAll Serial NumbersARTG Number:140333(Radiometer Pacific - Transcutaneous blood gas monitor)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd