Events

Retiro De Equipo (Recall) de Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve (PRV)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Synthes 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-2013-RN-00451-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-05-20
  • 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-2013-RN-00451-1
  • 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 hand piece' s outer hose can rupture without warning if the air flow is blocked during use, this issue involves all drill system hose assemblies manufactured prior to a design change that became effective on may 13, 2009 incorporating a pressure relief valve.
  • Acción
    End users are requested to inspect their stock to determine if they have any pneumatic drill systems without a pressure release valve. All affected device are to be returned to DePuy Synthes for rework/modification.

Device

Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve ...
  • Modelo / Serial
    Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve (PRV)ARTG Number: 141599
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd