Events

Retiro De Equipo (Recall) de Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope)

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-2013-RN-01256-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-29
  • 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-2013-RN-01256-1
  • 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
    Leica microsystems has identified that in certain activations of the xy, the system can continue to run laterally to its limit (run-on), but will stop if the surgeon activates any button. run-on of the xy can only occur in the rare situation of rapid consecutive activation on the 45 degrees, 135 degrees, 225 degrees or 315 degrees. in addition, the run-on will stop if any other activation of the xy occurs. the xy run-on is disruptive as the adjustment to the field of view could take up to 24 seconds longer than usual, however there is a low risk to patients.
  • Acción
    Leica is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent fix.

Device

Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope)
  • Modelo / Serial
    Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope)Material Number: 10448505Serial numbers: 260213001, 70613002, 80911001, 110613001, 180712001, 30913001Manufactured from 10 May 2010 to 18 November 2013ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd