Events

Recall of Philips IntelliVue Clinical Information Portfolio

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare 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
    57039
  • Event Risk Class
    Class 2
  • Event Number
    Z-0414-2011
  • Event Initiated Date
    2010-10-19
  • Event Date Posted
    2010-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95226
  • 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
    Display, cathode-ray tube, medical - Product Code DXJ
  • Reason
    Software: scheduling function of the philips intellivue clinical information portfolio releases d.00 through d.03. edits to a scheduled even frequency order may result in pending interventions not being generated after the first 24 hours.
  • Action
    Philips Healthcare issued an Urgent Medical Device Correction letter dated October 15, 2010 to customers. Customers are asked to follow the guidelines in the "Action to be taken by Customer/User" section of the Urgent Medical Device Correction Notice until they receive their software correction. The correction will be in the form of a software upgrade and will be performed by Philips service personnel. Contact Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377

Device

Philips IntelliVue Clinical Information Portfolio
  • Model / Serial
    Philips IntelliVue Clinical Information Portfolio Release D.XX, where XX is 00, 01, 02 or 03.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, including states of CA, DC, FL, IL, IN, KY, MA, MD, ME, NJ, NY, OK, RI, TX, VA, VT, and WV; and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, and the UNITED KINGDOM.
  • Product Description
    Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System || Software Version D.00 through D.03.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA