Events

Retiro De Equipo (Recall) de Leica Proveo 8 Ophthalmic Microscope 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 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-2017-RN-01247-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-30
  • 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-2017-RN-01247-1
  • 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
    Through customer complaints, leica has identified a series of intermittent issues with the leica proveo 8 ophthalmic microscope system, manufactured prior to july 2017.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 functionality of the hor recording unit. additionally, an anomaly in the device software may also lead to the unexpected behaviour that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. this behaviour 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.None of the observed issues were related to an actual or potential risk of patient or user injury. the system remains balanced and allows manual override of all main user functions at all time.
  • Acción
    Leica Microsystems is providing work around instructions for users to follow as an interim measure. A software and hardware upgrade will be implemented as a permanent correction.

Device

Leica Proveo 8 Ophthalmic Microscope System
  • Modelo / Serial
    Leica Proveo 8 Ophthalmic Microscope SystemSerial Numbers: 190216001, 060516001, 280916001 and 061216001Material Number: 10448808Manufactured prior to July 2017ARTG Number: 137683 (LEICA MICROSYSTEMS PTY LTD - Microscope, surgical)
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd