Events

Retiro De Equipo (Recall) de MicroGas 7650 Operator Manual used with Radiometer MicroGas 7650 Transcutaneous Monitor

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-00617-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-09
  • 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-00617-1
  • 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 storage temperature range for the combi m sensor 82 printed in the operators manual for microgas 7650 is incorrect. the operators manual states that the storage temperature range is -40c to +70c when it should be -10c to +50c as per the information supplied with the product.
  • Acción
    Radiometer is reiterating instructions on how to verify the performance of the sensor. An addendum to the instructions for use is also being provided with the correct storage conditions. This action has been closed-out on 15/08/2016.

Device

MicroGas 7650 Operator Manual used with Radiometer MicroGas 7650 Transcutaneous Monitor
  • Modelo / Serial
    MicroGas 7650 Operator Manual used with Radiometer MicroGas 7650 Transcutaneous MonitorSerial Numbers: All lotsAffects: COMBI M sensor 82 ; Item code: 0605000ARTG Number: 140334
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd