Events

Rappel de Device Recall eCare Coordinator

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 Visicu.

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
    76660
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1708-2017
  • Date de mise en oeuvre de l'événement
    2017-03-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-10-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153766
  • 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
    Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
  • Cause
    Ecarecoordinator (ecc) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. the software is intended to provide patient information from the patient location through networking technology to a remote care team. a software defect was discovered in the philips ecarecoordinator (ecc) clinical user interface that can at times cause missing or redundant data to be saved without notification to the user.
  • Action
    Field Safety Notice (FSN) will be sent to all customers using eCareCoordinator all Versions. The FSN describes the problem and circumstances in which the design defects occurs and the action planned by Philips to correct the problem. The FSN will also detail the functionality change in detail. A software correction will be made and released.by the vendor. Customers will have this correction applied to their current version when made available by Vendor in order to fix this correction.

Device

Device Recall eCare Coordinator
  • Modèle / numéro de série
    453564506091  eCareCoordinator
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-US Nationwide
  • Description du dispositif
    eCare Coordinator || Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCare Coordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.
  • Manufacturer
    Philips Visicu

Manufacturer

Philips Visicu
  • Adresse du fabricant
    Philips Visicu, 217 E Redwood St Ste 1900, Baltimore MD 21202-3315
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA