Events

Retiro De Equipo (Recall) de Device Recall multiple Laser Scanning Microscopes.

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
    80115
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2058-2018
  • Fecha de inicio del evento
    2018-05-08
  • Fecha de publicación del evento
    2018-06-09
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164575
  • 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
    Spectroscopy instrument - Product Code REM
  • Causa
    In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the class i limit.
  • Acción
    1.Your firm will send an initial email to all known users advising them of the issue, the risk involved and associated mitigations until the units can be evaluated by Carl Zeiss service representatives, 2.Your firm will send a second written communication to each first line purchaser and to each known user site with the notice of action and warning to discontinue use of the component until it has been verified as defective or properly functioning, and 3.Your firm will dispatch factory trained service representatives to perform verification tests and to replace defective units as necessary, free of charge. CDRH approves the CAP subject to the following conditions: For further questions, please call (914) 747-1800.. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Corrective actions will be provided at no cost to the purchasers and completed by March 1, 2019.

Device

Device Recall multiple Laser Scanning Microscopes.
  • Modelo / Serial
    Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    USA (nationwide)
  • Descripción del producto
    Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple || Laser Scanning Microscopes. || Laser scanning microscopes are used in cell biology research.
  • 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