Events

Recall of Device Recall Intellispace Portal and Extended Brillance Workspace

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) 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
    62005
  • Event Risk Class
    Class 2
  • Event Number
    Z-1987-2012
  • Event Initiated Date
    2012-05-23
  • Event Date Posted
    2012-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109682
  • 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, x-ray, tomography, computed - Product Code JAK
  • Reason
    The intellispace portal software and extended brillance workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "time sensitive" and "time insensitive" methods.
  • Action
    Philips Healthcare sent a Urgent Medical Device Correction letter dated May 31, 2012, to all affected customers. The letter was sent via certified mail to each customer. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. For any further information or support, customers can contact their local Philips representative or local Philips Healthcare office at (1-800-722-9377 Option 5 : Entersite ID or follow the prompts). Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. The user was informed that a field service representative will visit the facility to install the new software. Philips apologizes for any inconveniences caused by this problem.

Device

Device Recall Intellispace Portal and Extended Brillance Workspace
  • Model / Serial
    Model number: 881001; serial numbers: 85104, 80818, 85088, 82038, 81013, 80911, 82017, 80994, 81021, 81017, 81065, 81161, 81164, 81130, 81004, 81003 & 80979. Model number: 728260; serial numbers: 10102, 6483, 14691, 10155, 12050, 11169, 15016, 15677, 15658, 14834, 14955, 10173, 15018, 14171, 14170, 11994 & 11995.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Nationwide Distribution including the states of AZ, OR, PA and TX and the countries of Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, and United Kingdom.
  • Product Description
    IntelliSpace Portal software and Extended Brillance Workspace software || Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA