Events

Retiro De Equipo (Recall) de Panther and Panther Fusion Systems with 19-in monitor

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Hologic 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-00065-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-18
  • 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-00065-1
  • 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
    Hologic has been made aware that the touch screen monitor provided with certain panther and panther fusion systems has the potential for the glass panel to separate due to inadequate adhesion between the glass panel and the monitor. hologic has received 2 complaints where the glass panel separated from the panther monitor. to date, there have been no reports of injuries associated with this defect; however there is a potential risk that the glass panel may fall and injure an operator.
  • Acción
    Hologic will contact affected customers to arrange for an interim solution to secure the glass panel to be installed. Subsequently, a replacement monitor with this issue corrected will be installed once made available.

Device

Panther and Panther Fusion Systems with 19-in monitor
  • Modelo / Serial
    Panther and Panther Fusion Systems with 19-in monitorProduct code: 902615Serial Nos: 2090002307 to 2090002532Manufactured between April 2017 and Nov 2017ARTG Number: 260039 (Gen-Probe Australia Pty Ltd - Instrument/analyser IVDs)
  • Manufacturer
    Hologic Australia Pty Ltd

Manufacturer

Hologic Australia Pty Ltd