Events

Recall of Extended Brilliance Workspace Imaging Workstation

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
    29844
  • Event Risk Class
    Class 2
  • Event Number
    Z-0889-06
  • Event Initiated Date
    2004-08-02
  • Event Date Posted
    2006-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34642
  • 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, Image Processing, Radiological - Product Code LLZ
  • Reason
    Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.
  • Action
    Revised, corrected software has been shipped to consignees beginning June, 2004.

Device

Extended Brilliance Workspace Imaging Workstation
  • Model / Serial
    All serial numbers. Software version 1.0 or 1.0.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The systems were installed at medical facilities located nationwide and worldwide.
  • Product Description
    Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA