Events

Retiro De Equipo (Recall) de EmbryoScope Time-Lapse Incubator

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Gytech 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-00629-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-16
  • 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-00629-1
  • 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
    When cleaning or disinfecting parts of the embryoscope time-lapse incubator, the metal clips which are attached to the embryo chamber and support the transparent plate positioned over the culture dish holder may come loose.
  • Acción
    FertiiTech has updated the User Manual to include information on checking that the metal clips are in the correct position after cleaning. This amendment has been notified to end users. This action was undertaken prior to notifying the Therapeutic Goods Administration.

Device

EmbryoScope Time-Lapse Incubator
  • Modelo / Serial
    EmbryoScope Time-Lapse IncubatorReference Numbers: ESD20000, ESD200000-EU, ESD200000-JAP
  • Manufacturer
    Gytech Pty Ltd

Manufacturer

Gytech Pty Ltd