Events

Retiro De Equipo (Recall) de Device Recall Leica M525 OH4

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States 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
    64601
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2176-2013
  • Fecha de inicio del evento
    2012-12-18
  • Fecha de publicación del evento
    2013-09-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116798
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Microscope, surgical, general & plastic surgery - Product Code FSO
  • Causa
    The brake in the z axis and/or brakes in the ab and c axes failed during installation.
  • Acción
    The firm, Leica Microsystems, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to DISCONTINUE USE until your system software is updated and to complete and return the attached Acknowledgement Form via email at LMGRA@leica-microsystems.com or fax to: 847-236-3747 or +41 71 726 32 49 within 10 working days after receipt of field safety notice. Your Leica Mycrosystems will contact you to make the necessary arrangements to complete an upgrade at no charge to the customers. If you have any further questions, contact Regulatory Affairs/Quality Assurance Manager at 847-405-5413 or +41 71 726 32 16.

Device

Device Recall Leica M525 OH4
  • Modelo / Serial
    Serial Numbers: OH4-84712,  OH4-84812,  OH4-84912
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.
  • Descripción del producto
    Surgical microscope || The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
  • Manufacturer
    Leica Microsystems (Schweiz) Ag

Manufacturer

Leica Microsystems (Schweiz) Ag
  • Dirección del fabricante
    Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny-Strasse, Heerbrugg Switzerland
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA