Events

Recall of Device Recall Philips eCareManager System

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

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
    61328
  • Event Risk Class
    Class 2
  • Event Number
    Z-1474-2012
  • Event Initiated Date
    2012-02-22
  • Event Date Posted
    2012-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107808
  • 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
    System,network and communication,physiological monitors - Product Code MSX
  • Reason
    Three versions of software for the ecaremanager failed to display anticoagulants on the medications screen. the problem arose due to an unexpected change in the national drug data file.
  • Action
    Philips notified all affected customers via a preliminary email message advising them of the issue. An URGENT - Field Safety Notice follow-up letter was mailed to all customers on February 22, 2012. This letter identified the affected product, described the problem and circumstances in which it can occur; recommend actions the customer should take to prevent risks for patients, and list the actions planned by Philips to correct the problem. For questions contact Philips eICU Customer Support 877-374-2872.

Device

Device Recall Philips eCareManager System
  • Model / Serial
    v3.7, v3.7.1, v3.8
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including states of MA, MO, WI, AR, AZ, PA, SD, VA, and IN.
  • Product Description
    Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. || Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinical information management with independent bedside devices and ancillary systems that are connected either directly or through networks. The eCareManager system provides patient information and surveillance of monitored patients at the point of care location and at a remote, supplementary care location through wide area networking technology and dedicated phone lines and is solely intended for use in a hospital environment. It is not intended to be used in a home environment.
  • Manufacturer
    Visicu, Inc.

Manufacturer

Visicu, Inc.
  • Manufacturer Address
    Visicu, Inc., 217 E Redwood St Ste 1900, Baltimore MD 21202-3315
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA