Events

Retiro De Equipo (Recall) de V-PRO 60 Low Temperature Sterilisation System with VAPROX HC Sterilant Distributed between 31 July 2014 and 17 August 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 Device Technologies 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-2017-RN-01395-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-07
  • 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-2017-RN-01395-1
  • 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
    Device technologies has identified a software issue where the v-pro 60 software verifies expiration date of the vaprox sterilant upon completion of the sterilisation cycle rather than prior to cycle initiation. verification of the vaprox expiration date at the end of the sterilisation cycle will allow for the completion of one cycle with expired vaprox sterilant. to date, the manufacturer steris has not received any reports of adverse events related to this issue.
  • Acción
    Device Technologies is advising users that microbial efficacy studies support a safety margin for use of the product for three days after the indicated expiry date. Users are advised to ensure the cycle printout indicates the expiration date of the Sterilant upon the completion of each cycle and change the sterilant if required. Instruments processed in a cycle with sterilant more than three days beyond its expiry date are not considered properly sterilised and should be reprocessed with a new cup of sterilant before use. Device Technologies will be performing a software update as a permanent correction.

Device

V-PRO 60 Low Temperature Sterilisation System with VAPROX HC Sterilant Distributed between 31 Jul...
  • Modelo / Serial
    V-PRO 60 Low Temperature Sterilisation System with VAPROX HC SterilantDistributed between 31 July 2014 and 17 August 2017ARTG Number: 154905
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd