Events

Retiro De Equipo (Recall) de Device Recall iSite PACS Versions 4.1.x up to and including 4.1.51.3

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 Philips Healthcare Informatics, 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
    50751
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0948-2009
  • Fecha de inicio del evento
    2008-12-29
  • Fecha de publicación del evento
    2009-01-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76977
  • 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
    Picture Archiving and Communications System - Product Code LLZ
  • Causa
    Product may display clinical reports with the study date and time in gmt format, which may not be obvious to the end user, who may expect to see the local time in the report.
  • Acción
    Product notification was issued on 12/29/2008, instructing users to identify affected products, and instructing users to refer to image overlays for local study date and time information. The firm is planning a field correction expected to be available in "Q1 2009". For additional information, contact Philips at 650-293-2624.

Device

Device Recall iSite PACS Versions 4.1.x up to and including 4.1.51.3
  • Modelo / Serial
    Versions 4.1.x up to and including 4.1.51.3
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International - Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, and Brazil.
  • Descripción del producto
    iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster City, CA. || Device is an image management system intended to be used by trained professionals, and is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage
  • Manufacturer
    Philips Healthcare Informatics, Inc.

Manufacturer

Philips Healthcare Informatics, Inc.
  • Dirección del fabricante
    Philips Healthcare Informatics, Inc., 4100 E 3rd Ave Ste 101, Foster City CA 94404-4819
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA