Events

Retiro De Equipo (Recall) de Leica M525 OH4 and M720 OH5 Surgical Microscope Stands with 400W Illumination

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Leica Microsystems 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-2016-RN-00158-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-11
  • 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-2016-RN-00158-1
  • 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
    It has come to the manufacturer's attention that an electronic component of the leica m525 oh4 and leica m720 oh5 surgical microscopes with 400w illumination could lead to an unforeseen behaviour:an electronic component in one of the two illumination units can potentially overheat, resulting in modest smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.
  • Acción
    Leica is advising users that the microscope will continue to function if the failure occurs, and is providing users with instructions on how to switch the microscope to the back-up illumination unit. Leica will be providing a replacement power supply cable to prevent the issue from occurring. This action has been closed-out on 25/01/2017.

Device

Leica M525 OH4 and M720 OH5 Surgical Microscope Stands with 400W Illumination
  • Modelo / Serial
    Leica M525 OH4 and M720 OH5 Surgical Microscope Stands with 400W IlluminationMaterial Numbers: 10448480 and 10448662Serial Numbers: OH5-31311, OH5-51813, OH5-53113, OH5-55313, OH5-53413, OH5-57013, OH5-56613, OH4-107114 and OH5-67314ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd