Events

Retiro De Equipo (Recall) de Device Recall iSite PACS software versions 3.6.28.x and 4.1.x.

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
    49403
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0118-2009
  • Fecha de inicio del evento
    2008-08-29
  • Fecha de publicación del evento
    2008-10-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73260
  • 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 Communication System - Product Code LLZ
  • Causa
    Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using conference presentation states and when opening two or more studies from a folder or an exam worklist and 2) potential to miscalculate measurements when pixel spacing and imager pixel spacing dicom tag values are bot.
  • Acción
    A notification letter (Urgent Product Correction) dated 8/29/08 was sent via certified mail to all customers alerting them of the issue, requiring posting of notification. Philips Healthcare Informatics, Inc. strongly recommend all customers advise their iSite Radiology users not to open multiple patient exams simultaneously from a folder or worklist using Conference Presentation States. A software correction is being worked on, and should be available by end of Q3 2008 for version 4.1.45.2. A mandatory upgrade is required for all customers who are currently using iSite version 4.1.45.2 and former versions. For specific questions regarding these issues, contact the Customer Advocate (CARE) or Customer Care at Philips Healthcare Informatics, Inc. at 1-877-328-2808. In your communication with Customer Care at Philips Healthcare Informatics, Inc. , please refer to this notification and associated FCO 22945704-08292008-004.

Device

Device Recall iSite PACS software versions 3.6.28.x and 4.1.x.
  • Modelo / Serial
    Software versions 3.6.28.x and 4.1.x.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA (MN, CO and PA) and countries of Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia.
  • Descripción del producto
    iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. || The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.
  • 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