Events

Recall of Device Recall Philips Intellispace Portal

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems Nederlands.

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
    61043
  • Event Risk Class
    Class 2
  • Event Number
    Z-1125-2012
  • Event Initiated Date
    2012-01-27
  • Event Date Posted
    2012-02-29
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107164
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    There maybe incorrect values in the diffusion/perfusion maps.
  • Action
    Philips issued URGENT - Medical Device Correction Notifications, dated January 20, 2012. The letter identified the affected product, all Intellispace Portal with software release 4.0.0 Installed, and gave a description of the problem. Users were provided with the actions to be taken prior to the software upgrade( to version 4.0.1). Users are to follow the instructions provided in order to generate maps with the correct values and to make sure that the setting is correct before using the generated data. Philips will contact customers in order to install the update free of charge. Customers should contact their local Philips representative at 866-767-2822

Device

Device Recall Philips Intellispace Portal
  • Model / Serial
    Software release 4.0.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including states of IN and TX, and countries of Australia, Austria, Czech, Denmark, France, Germany, Indonesia, Netherlands, Poland, Spain, and Switzerland.
  • Product Description
    Philips Intellispace Portal, Release 4.0.0. || For storing, processing and management of electronic information/data || Model: 881001. || Indicated for use as a diagnostic device.
  • Manufacturer
    Philips Medical Systems Nederlands

Manufacturer

Philips Medical Systems Nederlands
  • Manufacturer Address
    Philips Medical Systems Nederlands, Veenpluis 4-6, Best Netherlands
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA