Events

Recall of Philips IntelliSpace ECG Management System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems, 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
    68983
  • Event Risk Class
    Class 2
  • Event Number
    Z-2535-2014
  • Event Initiated Date
    2014-08-07
  • Event Date Posted
    2014-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129200
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Reason
    Philips intellispace ecg (iecg) management systems that are importing stress ecg records from a quinton stress ecg system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name, patient id (pid), medical record number (mrn). this creates the potential for misdiagnosis and incorrect therapy.
  • Action
    Philips Healthcare sent an Urgent Medical Device Correction Notification / Field Safety notice dated August 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice is intended to inform you about: " what the issue is and under what conditions it can occur " the actions that should be taken by the customer/user in order to prevent risks for patients " the corrective action planned by Philips to address the following issue 1)Previously Imported Stress Records: Institutions that have imported Quinton Stress ECG records into IECG should review each previously imported record to make sure that multiple patient ID data is not present. Institutions that imported stress records at the end of each stress exam or did not batch process the records should not find any records with multiple Patient IDs in the record. However, we do recommend that you perform the review to confirm that multiple Patient IDs do not exist. 2) Continued Use: Software is now available to address the issue described in this letter. If you have not already been contacted by Philips please call to arrange for immediate installation of the software upgrade. The correction will consist of free of charge software upgrade to A.01.06.. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Further information or support concerning this issue, please contact your local Philips representative or call us at 1-800-722-9377

Device

Philips IntelliSpace ECG Management System
  • Model / Serial
    Model No. 860426  Serial Numbers: US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051, US51300008, US51400056, US81300016, USN1300020
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including the states of CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain.
  • Product Description
    Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. || Model No. 860426
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA