Events

Retiro De Equipo (Recall) de Runyes Autoclave17L, 22L B Class Manufactured between 2012 & 2017

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medical Equipment 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-2018-RN-00001-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-12
  • 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-00001-1
  • 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
    Medical equipment australia has been made aware of an issue regarding the failure of cycles when the negative pressure is not within a specified range. affected devices will be provided with a software update to rectify the issue of monitoring critical parameters during a cycle and generate a 'fail' if they are not reached.
  • Acción
    Medical Equipment Australia will arrange a service technician to be in contact with users to arrange for software upgrade to correct this issue. In the interim, users should refer to the tests outlined in the customer letter to verify that their equipment is functioning correctly.

Device

Runyes Autoclave17L, 22L B Class Manufactured between 2012 & 2017
  • Modelo / Serial
    Runyes Autoclave17L, 22L B ClassManufactured between 2012 & 2017Multiple Affected Serial NumbersARTG Number: 197900 (Medical Equipment Australia Pty Ltd - Sterilizer, moist heat, fluid)
  • Manufacturer
    Medical Equipment Australia Pty Ltd

Manufacturer

Medical Equipment Australia Pty Ltd