Events

Retiro De Equipo (Recall) de Device Recall GC80 Digital Xray Imaging System

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 NeuroLogica Corporation.

¿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
    78679
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0726-2018
  • Fecha de inicio del evento
    2017-06-22
  • 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=160105
  • 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
    System, x-ray, stationary - Product Code KPR
  • Causa
    An image was obtained with over exposure during a thorax examination using the aec function.
  • Acción
    On June 22, 2017, Samsung distributed Urgent Field Safety Notices & acknowledgment forms to their customers via email. INSTRUCTIONS FOR END USERS: 1) Please read the Field Safety Notice documentation in detail. 2) Follow the instructions provided in this FSN in relation to any actions which are required of you. 3) Complete the provided acknowledgement form and return to your supplier as soon as possible. Your organizations reply is the evidence we need to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible. INSTRUCTIONS FOR DISTRIBUTORS: 1) Please read the Field Safety Notice documentation in detail. 2) Please review and complete the acknowledgement form provided in this FSN and return to Samsung as soon as possible. Please pass this entire package of FSN documentation onto your customers and ask them to return the completed acknowledgement form. Please forward copies of acknowledgements from end users onto to the email addresses stated above. Samsung require this evidence to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible. Customers with questions were advised to contact their local representative.

Device

Device Recall GC80 Digital Xray Imaging System
  • Modelo / Serial
    Accession Number 1310459
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide US
  • Descripción del producto
    The GC80 Digital X-ray Imaging System
  • Manufacturer
    NeuroLogica Corporation

Manufacturer

NeuroLogica Corporation
  • Dirección del fabricante
    NeuroLogica Corporation, 14 Electronics Ave, Danvers MA 01923-1011
  • Empresa matriz del fabricante (2017)
    Samsung Electronics Co., Ltd.
  • Source
    USFDA