Retiro De Equipo (Recall) de Auriga XL 4007 Laser System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Boston Scientific 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Boston scientific has identified specific auriga xl 4007 laser consoles have been produced with the incorrect laser warning label applied to the console. the labels on the affected consoles provide incorrect information regarding the maximum power (p) and the wavelength (?) actually emitted by the console. the two potentially impacted elements related to the laser warning label being incorrect are: the selection/ordering of laser protection goggles and the arrangement or ‘setup' of the laser use area.
  • Acción
    A Boston Scientific Certified Field Service Engineer (FSE) will replace the console’s Laser Warning Label with the correct Label. Users are advised to continue to follow the use and room setup instructions per Auriga XL User Manual (91043397). No further action is required by the users prior to the FSE visit.


  • Modelo / Serial
    Auriga XL 4007 Laser SystemMaterial Number (UPN): M00684007GO Serial Numbers: 4007-A-076 and 4007-A-078 ARTG Number: 287772
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source