Events

Retiro De Equipo (Recall) de Leica M525 F40 Surgical Microscopes

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-00771-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-29
  • 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-2017-RN-00771-1
  • 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 the instructions for use (ifu) and warnings are not always followed by users of the leica m525 f40 surgical microscopes, in particular for transportation and positioning in the operating room (or). due to this, additional waning stickers have been introduced for the leica m525 f40, in addition to a quick reference guide for transporting and position in the or which can be attached to the instrument.Using the m525 f40 improperly during transport and positioning can have an adverse effect on the stability of the device. in extreme cases, improper use during transport and positioning can cause tilting of the device. leica microsystems has received two reports where a m525 f40 started tilting due to improper handling.
  • Acción
    1. Leica Microsystems is sending warning stickers and “quick reference guides for transport and positioning in the OR”. 2. Users are to arrange the fixation of the warning stickers on the instruments, inform or personnel accordingly and fill out the supplied acknowledge form.

Device

Leica M525 F40 Surgical Microscopes
  • Modelo / Serial
    Leica M525 F40 Surgical MicroscopesMaterial Number: 10448096Serial Numbers: 010708001, 010906002, 060505002, 080508001, 100105001, 100608002, 110608001, 180205002, 180410001, 230507001, 231209001, 240609001, 260609001, 290508001, 301106002ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd