Events

Recall of Device Recall eCare Coordinator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Visicu.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76660
  • Event Risk Class
    Class 2
  • Event Number
    Z-1708-2017
  • Event Initiated Date
    2017-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153766
  • Notes / Alerts
    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.
  • Extra notes in the data
    Transmitters and receivers, physiological signal, radiofrequency - Product Code DRG
  • Reason
    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
  • Model / Serial
    453564506091  eCareCoordinator
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US Nationwide
  • Product Description
    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
  • Manufacturer Address
    Philips Visicu, 217 E Redwood St Ste 1900, Baltimore MD 21202-3315
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA