Events

Recall of Philips medical Systems

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
    53593
  • Event Risk Class
    Class 2
  • Event Number
    Z-0418-2010
  • Event Initiated Date
    2009-10-21
  • Event Date Posted
    2009-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85943
  • 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
    A software defect exists in the icip release 0.02 scheduling function for order management such that if a user edits either the schedule time or the stop time for an existing order, the corresponding intervention(s) for the order may not be created.
  • Action
    Philips Medical Systems notified accounts by letter on October 21, 2009, of the release ICIP version D.03, which contains a software correction . A Philips representative will schedule the implementation of this upgrade. Please contact the Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377.

Device

Philips medical Systems
  • Model / Serial
    S/W Version D.02
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MD, RI, WV, and TX Australia Belgium Denmark France Italy Malaysia Singapore Spain Switzerland Taiwan United Arab Emirates United Kingdom and Ireland
  • Product Description
    IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. || Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
  • 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