Events

Retiro De Equipo (Recall) de Carl Zeiss Microimaging LaserTIRF (Total Internal Reflection Fluorescence

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 Zeiss, Carl Inc.

¿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
    59285
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1128-2012
  • Fecha de inicio del evento
    2011-04-28
  • Fecha de publicación del evento
    2012-02-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102128
  • 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
    Research laser - Product Code REK
  • Causa
    The manufacturer confirmed that the opto-semiconductor sensors can be triggered by exposure to incandescent lighting. the safety interlock is in place to prevent unintended exposure to class 3b laser radiation.
  • Acción
    Carl Zeiss MicroImaging LLC, through trained personnel, first visited each user site, provided additional user instructions, re-labeled the components to provide adequate instruction and warning and further placed a label over the access to the locking screw which secures the component to the microscope. Carl Zeiss Inc. issued "IMPORTANT LASER SAFETY NOTICE: URGENT: FIELD CORRECTIVE ACTION" notices to each user by express courier in late April 2011, Carl Zeiss personnel will confirm that the relabeling has been performed and updated instructions for use have been provided. For questions, please contact the company. The firm will implement 2 actions. Service Representatives will visit each user site, provide additional user instructions, relabel the components to provide adequate instruction and warning, and add a label over the access to the locking screw which secures the component to the microscope. Secondly, when new replacement sensors are available, Carl Zeiss field service technicians will perform the component replacements. Modified components are anticipated to be available within 6 months and replacement completed by April 2012.

Device

Carl Zeiss Microimaging LaserTIRF (Total Internal Reflection Fluorescence
  • Modelo / Serial
    All units manufactured are subject to correction.
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide)
  • Descripción del producto
    Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The Laser-TIRF Imaging-System is a Class 3B laser system. || The Laser TIRF Imaging System allows the visualization of substances or molecules being capable of fluorescing (excitable by light) by means of an electromagnetic (evanescent) field produced by total internal reflection.
  • Manufacturer
    Zeiss, Carl Inc

Manufacturer

Zeiss, Carl Inc
  • Dirección del fabricante
    Zeiss, Carl Inc, 1 Zeiss Dr, Thornwood NY 10594-1939
  • Empresa matriz del fabricante (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA