Events

Retiro De Equipo (Recall) de Leica Ceiling Mounts MSF-1, MS-1F and MC-1F (Used for mounting 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-2013-RN-00935-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-06
  • 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-00935-1
  • 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 is notifying their customers of an important safety issue concerning the ceiling supply units csu 80xx/ csu 60xx, manufactured from 1997 - 2003. the ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. as a result, the lift arm fell down approximately 60 cm (23.6 inches).
  • Acción
    Leica Microsystems is contacting their customers to arrange for the complete inspection of the ceiling mount and is providing customers with additional preventative maintenance protocols.

Device

Leica Ceiling Mounts MSF-1, MS-1F and MC-1F (Used for mounting surgical microscopes)
  • Modelo / Serial
    Leica Ceiling Mounts MSF-1, MS-1F and MC-1F (Used for mounting surgical microscopes)Leica Ceiling Mount MSF-1Art. Numbers: 10446781 & 10446782Leica Ceiling Mount MS-1F & MC-1FArt. Numbers: 10446657 & 10446658ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd