Events

Retiro De Equipo (Recall) de V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation Systems Manufactured between 2 January 2014 and 2 May 2016

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-2016-RN-00803-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-06-20
  • 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-2016-RN-00803-1
  • 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
    Steris has identified that v-pro 1, v-pro 1 plus, and v-pro max sterilisers manufactured after 1 january 2014 may not display the correct date as of 29 february 2016. while the v-pro units display an incorrect date, the steriliser functions and cycle operations continue to operate properly. if users do not manually change the system date of the v-pro unit, the unit’s display and cycle printout will contain an incorrect date.
  • Acción
    Device Technologies is advising users that a service technician will be upgrading all affected systems. Users are advised that the system date can be amended using the instructions found in the Operator's Manual. The system can continue to be used as normal until corrected. This action has been closed-out on 11/05/2017.

Device

V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation Systems Manufactured between 2 Jan...
  • Modelo / Serial
    V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilisation SystemsManufactured between 2 January 2014 and 2 May 2016ARTG Number: 154905
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd