Events

Rappel de Device Recall iSite PACS Versions 4.1.x up to and including 4.1.51.3

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Healthcare Informatics, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    50751
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0948-2009
  • Date de mise en oeuvre de l'événement
    2008-12-29
  • Date de publication de l'événement
    2009-01-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-11-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76977
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Picture Archiving and Communications System - Product Code LLZ
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Versions 4.1.x up to and including 4.1.51.3
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International - Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, and Brazil.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Philips Healthcare Informatics, Inc., 4100 E 3rd Ave Ste 101, Foster City CA 94404-4819
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA