Events

Retiro De Equipo (Recall) de Device Recall Retcam3 & Retcam Shuttle with version

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 Clarity Medical Systems 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
    61180
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1099-2012
  • Fecha de inicio del evento
    2012-02-02
  • Fecha de publicación del evento
    2012-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107470
  • 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
    Camera, ophthalmic, Ac-powered - Product Code HKI
  • Causa
    Still images extracted from video recordings may be mislabeled as to right and left eye.
  • Acción
    Clarity Medical Systems, Inc. sent a Safety Alert letter dated February 7, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed the following : 1. Do not use the video mode until the software has been updated. 2. Install the software update using the enclosed CD. The instructions for installation are also enclosed. This software update will correct the anomaly. 3. If you have extracted still images from video recordings, review all potentially affected patient files to determine if any right eye images are mislabeled as left eye images and/or left eye images are mislabeled as right eye images. If any images are mislabeled, make the appropriate corrections in the annotation section of the affected file. Consider whether there is any diagnostic impact or need to re-irnage the patient. We apologize for the inconvenience. If you have questions or concerns, please contact Clarity at 800-215-6005.

Device

Device Recall Retcam3 & Retcam Shuttle with version
  • Modelo / Serial
    Model number RC3, part number 21-100500; Model number RCS, part number 20-000300.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the states of TN, MO, TX, FL, NJ and Puerto Rico and countries of Italy, Portugal, Czech Republic, Thailand, Chile, Oman, Hong Kong, Russia, Philippines, Sweden, Finland, Ecuador, Australia and Canada.
  • Descripción del producto
    Retcam3 & Retcam Shuttle with version 6.0 software. || Clarity Medical Systems, Inc. || 5775 W. Las Positas Blvd, Suite 200 || Pleasanton, CA 94588 || General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
  • Manufacturer
    Clarity Medical Systems Inc

Manufacturer

Clarity Medical Systems Inc
  • Dirección del fabricante
    Clarity Medical Systems Inc, 5775 W Las Positas Blvd, Pleasanton CA 94588
  • Empresa matriz del fabricante (2017)
    Natus Medical Incorporated
  • Source
    USFDA