Events

Retiro De Equipo (Recall) de neoBLUE blanket LED Phototherapy SystemsDevice Numbers:007301 neoBLUE blanket LED Phototherapy System with Large blanket/pad; AUS power cord 007302 neoBLUE blanket LED Phototherapy System with Small blanket/pad; AUS power cord

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Paragon Healthcare 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-00043-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-19
  • 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-00043-1
  • 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
    A potential issue of discolouration/degradation/melting of the fiber optic bundle at the pad connector which is inserted in the neoblue blanket light box has been identified. the manufacturer is in the process of confirming an updated neoblue blanket configuration which will not be susceptible to the degradation issue. (please note that the date of project completion is uncertain at this time.).
  • Acción
    Paragon is requesting users to continue to check the fiber optic connection before use as described in the Technical Bulletin. Users are advised to refer to the Technical Bulletin for further important information and that they will be contacted for a replacement or upgrade when the updated configuration is available.

Device

neoBLUE blanket LED Phototherapy SystemsDevice Numbers:007301 neoBLUE blanket LED Phototherapy Sy...
  • Modelo / Serial
    neoBLUE blanket LED Phototherapy SystemsDevice Numbers:007301 neoBLUE blanket LED Phototherapy System with Large blanket/pad; AUS power cord 007302 neoBLUE blanket LED Phototherapy System with Small blanket/pad; AUS power cordSerial numbers up to and including xxxx004282 ARTG Number: 97472
  • Manufacturer
    Paragon Healthcare Pty Ltd

Manufacturer

Paragon Healthcare Pty Ltd