Events

Retiro De Equipo (Recall) de Device Recall VISU 200

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
    52716
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0904-2011
  • Fecha de inicio del evento
    2009-05-18
  • Fecha de publicación del evento
    2011-01-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83806
  • 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
    Potential retina damage-- an error in the user manual may result in misapplied filter and injury during treatment.
  • Acción
    Carl Zeiss Meditec Inc sent a SAFETY ALERT letter dated May 18, 2009, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were reminded to use the correct retinal protection filter (GG475) when using the OPMI VISU 200 system during ophthalmic surgery. Verify the position of the retinal protection filter and inform their staff of the customizable feature. Verify that the correct filter was in place. Customers were asked to complete the acknowledgement form indicating receipt of the alert. Sign and return the form to: Carl Zeiss Meditec in Dublin, California via the enclosed self-addressed, pre-paid Federal Express envelope. For any questions customers should call (925) 557-4422.

Device

Device Recall VISU 200
  • Modelo / Serial
    User manuals with numbers G-30-1246-e, G-30-1284-e, G-30-1284-en, and G-30-1236-en, affecting all stands.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA (nationwide) and the UK
  • Descripción del producto
    VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany || Medical device: Surgical microscope used during ophthalmic surgeries, which allows real time visualization of the surgical area. || Product Quantity Distributed (Int) 2540 units
  • Manufacturer
    Carl Zeiss Meditec Inc

Manufacturer

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