Events

Retiro De Equipo (Recall) de Leica M525 F50/C50 Surgical Microscope with XY-Unit

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Leica Microsystems (Schweiz) AG.

¿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
    15750
  • Fecha de inicio del evento
    2013-12-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Pacific Dental Specialties Limited, 3 Clyde Road, Napier Hill, Napier 4110
  • Causa
    Leica microsystems (schweiz) ag has discovered 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°, 135°, 225°, or 315°. in addition, the run-on will stop if any other activation of the xy occurs.
  • Acción
    Software to be upgraded

Device

Leica M525 F50/C50 Surgical Microscope with XY-Unit
  • Modelo / Serial
    Model: M525 F50 & M525 C50 with XY units, Affected: , Software version: Software versions prior to Pack D
  • Manufacturer
    Leica Microsystems (Schweiz) AG

Manufacturer

Leica Microsystems (Schweiz) AG