Events

Retiro De Equipo (Recall) de neoBLUE LED Phototherapy Lights (2nd Generation)

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-00466-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-26
  • 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-00466-1
  • 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 neoblue 2 systems were manufactured using individual leds of higher intensity output than the original product specification. to compensate for this higher intensity, customers were previously advised to increase the distance between the phototherapy light and the patient. the neoblue 2 light is now being recalled and replaced with the current generation light.
  • Acción
    Paragon Care is requesting customers identify if they have affected stock by checking for a black band around the light enclosure base. If so, users are requested to record the Serial number (located on the back panel of the light enclosure) on the reply form and return the completed form in order to receive a free replacement. Users are then advised to place the affected light in the box which contained the replacement prior to its return to Paragon Care.

Device

neoBLUE LED Phototherapy Lights (2nd Generation)

Manufacturer

Paragon Healthcare Pty Ltd