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
    73673
  • Event Risk Class
    Class 2
  • Event Number
    Z-1557-2016
  • Event Initiated Date
    2016-03-10
  • 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=144720
  • 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
    The adherence check generates a software error. two issues occur as a result of the software error: 1) no adherence flag is generated for that day; 2) no task is generated for the date 14 days later. an error message is generated and forwarded to operations. subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement. if the pa.
  • Action
    1. Field Safety Notice(FSN) will be sent to all customers using eCareCoordinator v.1.3 platform. The FSN describes the problem and the circumstances in which the design defects occur and the action planned by Philips to correct the problem. The FSN will also detail the functionality change in detail. 2. A software correction will be made and released. Customers will be upgraded to eCC v.1.4. The v.1.4 is scheduled to be released on or about 8 March 2016. The defect will have been corrected and tested.

Device

Device Recall eCare Coordinator
  • Model / Serial
    453564506091 eCareCoordinator 1.3
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.
  • Product Description
    eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). || For medical use by professional medical staff.
  • 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