Events

Recall of Device Recall Brilliance CT Systems

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
    38264
  • Event Risk Class
    Class 2
  • Event Number
    Z-0111-2008
  • Event Initiated Date
    2007-05-25
  • Event Date Posted
    2007-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53274
  • 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
    Computed tomography scanner - Product Code JAK
  • Reason
    Two potential artifacts may appear in some images from head scans on the brilliance 40/64 systems. these artifacts may lead to misdiagnosis.
  • Action
    Firm notified its customers via a Product Safety Notification letter dated May 25, 2007, warning the user of a possible appearance of artifacts which could lead to a misdiagnosis and improper treatment.

Device

Device Recall Brilliance CT Systems
  • Model / Serial
    Model No. 728235. Version 2.2.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Argentina, Austria, Australia, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Denmark, Ecuador, Egypt, England, Equatorial Guinea, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Korea, Lebanon, Libya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Phillipines, Poland, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, Uzbekistan, Venezuela, and West Indies.
  • Product Description
    Brilliance CT Systems 64 slice configuration. Computed tomography scanner.
  • 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