Events

Retiro De Equipo (Recall) de LEICA PROVEO 8 OPHTHALMIC MICROSCOPE SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada 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
    102904
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-09-12
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    For the leica ophthalmic surgical microscope platform proveo 8 a series of intermittent issues which negatively influenced customer satisfaction were identified through customer complaints. the observed issues can lead to unexpected interruptions of the optics carrier focus drive movement intermittent stops of the x-y coupling movement or sporadic failures in the proper on-screen display funtionality of the hdr recording unit. additionally an anomaly in the device software may also lead to the unexpected behavior that when a user releases a handle or foot switch button this may not immediately end the actuated funtionality. this behavior can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated.

Device

LEICA PROVEO 8 OPHTHALMIC MICROSCOPE SYSTEM
  • Modelo / Serial
    Model Catalog: 10448808 (Lot serial: 011216001); Model Catalog: 10448808 (Lot serial: 041216001); Model Catalog: 10448808 (Lot serial: 230516001)
  • Descripción del producto
    Leica PROVEO 8 Ophthalmic Microscope System
  • Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG

Manufacturer

LEICA MICROSYSTEMS (SCHWEIZ) AG