Events

Recall of Device Recall eCareManager

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
    70931
  • Event Risk Class
    Class 2
  • Event Number
    Z-0399-2016
  • Event Initiated Date
    2015-03-27
  • Event Date Posted
    2015-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135619
  • 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
    A software defect may cause incorrect medication order change. if the user decides to edit the order prior to electronic signature and selects the return to previous screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. at the stage where the order is signed, the medication displayed may be incorrect.
  • Action
    Philips Visicu sent an "Field Safety Notification" to all affected customers still using an affected version of eCareManager. (4 Customers) 03/27/2015 The letter identified the problem and circumstances in which the defect can occur; recommend actions the customer should take to prevent risks for patients; and list the actions planned by Philips to correct the problem. "Philips Hospital to Home has taken corrective action to address the software defect in all supported versions of eCareManager software. Philips Hospital to Home is working with affected customers to complete the necessary upgrade. Please contact your local Philips Representative for further questions.

Device

Device Recall eCareManager
  • Model / Serial
    eCareManager v3.7, 3.7.1, v3.8, and v3.9
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution only.
  • Product Description
    The eCareManager system. Software 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. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.
  • 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