Events

Retiro De Equipo (Recall) de Zeiss Surgical Microscopes,OPMI Pentero, OPMI Vario,OPMI Neuro

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 Carl Zeiss Meditec, 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
    59908
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3275-2011
  • Fecha de inicio del evento
    2011-09-12
  • Fecha de publicación del evento
    2011-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103973
  • 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 - Product Code EPT
  • Causa
    Some third party surgical drapes have optically active protective lenses that could affect the zeiss surgical microscope position information that is passed on to third party navigation systems.
  • Acción
    The firm, Zeiss, sent an "IMPORTANT SAFETY ALERT FOR ZEISS SURGICAL MICROSCOPES" letter dated September 7, 2011, to all affected customers. The letter described the product, problem and action to be taken. The customers were instructed to use surgical drapes compatible with ZEISS surgical microscopes and always follow the instructions for use of the third party navigation system manufacturer for calibration, calibration verification and operation. In addition, the firm supplied customers with a supplement to their Zeiss surgical microscope user documentation and requested that they read the information and keep a copy with their original instructions also the customers were instructed to complete and return the Acknowledgement of Receipt form within 5 business days via fax to 1-866-809-6044 or USPS to Stericycle, Inc., Attn: Event 2480, 2670 Executive Dr. Suite A, Indianapolis, IN 46241. Should you have any questions about this Safety Alert, please contact your Carl Zeiss Customer Care representative at 1-888-871-7120.

Device

Zeiss Surgical Microscopes,OPMI Pentero, OPMI Vario,OPMI Neuro
  • Modelo / Serial
    All-OPMI¿ Pentero¿, OPMI¿ Pentero¿ C, OPMI¿ Pentero¿ 900, OPMI¿ Vario/S8, OPMI¿ Vario/S88, OPMI¿ Neuro Multivision/NC4,  OPMI¿ Vario/NC33, OPMI¿ Neuro/NC4, OPMI¿ Neuro/NC4 Ceiling Mount.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA only.
  • Descripción del producto
    OPMI¿ Pentero¿, OPMI¿ Pentero¿ C, OPMI¿ Pentero¿ 900, || OPMI¿ Vario/S8, OPMI¿ Vario/S88, OPMI¿ Neuro Multivision/NC4, || OPMI¿ Vario/NC33, OPMI¿ Neuro/NC4, OPMI¿ Neuro/NC4 Ceiling Mount. || A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area.
  • Manufacturer
    Carl Zeiss Meditec, Inc.

Manufacturer

Carl Zeiss Meditec, Inc.
  • Dirección del fabricante
    Carl Zeiss Meditec, Inc., 5160 Hacienda Dr, Dublin CA 94568-7562
  • Empresa matriz del fabricante (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA