Events

Retiro De Equipo (Recall) de Test Tube Heater - Power Supply UnitTest Tube Heater

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook Australia 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-2014-RN-00924-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-08-22
  • 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-2014-RN-00924-1
  • 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
    The power supply of the devices are being replaced because recent testing of the combination of the test tube heater and power supply was found to exceed the prescribed electromagnetic compatibility (emc) limits for radiated emissions.As the level of excess emissions are only slightly over the prescribed limits, and because the exposure to the radio frequency (rf) fields is far below internationally accepted safety levels, it is unlikely that there are any health risks to the user or patient posed by the non-conforming combination of the test tube heater (k-fth-1012) and power supply (k-aps-300). it is also unlikely for the power supply to affect the operation of the test tube heater as this device is designed to have rf immunity greater than the radiation emitted by the power supply.
  • Acción
    William A. Cook Australia will provide an alternative power supply unit. End users are requested to discontinue use and destroy the affected units. This action has been closed-out on 01/03/2016.

Device

Test Tube Heater - Power Supply UnitTest Tube Heater
  • Modelo / Serial
    Test Tube Heater - Power Supply UnitTest Tube Heater Part Number: K-FTH-1012Power Supply Unit Part Number: K-APS-300ARTG Number: 140546
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd