Events

Recall of Device Recall Brillance CT System

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
    69123
  • Event Risk Class
    Class 2
  • Event Number
    Z-2709-2014
  • Event Initiated Date
    2005-12-27
  • Event Date Posted
    2014-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129682
  • 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 system has a gap that can appear between the upper and lower tilt stand covers. the fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.
  • Action
    Customers will be contacted by a field service technician with the field correction order. The firm will install the new labeling to the device.

Device

Device Recall Brillance CT System
  • Model / Serial
    728256, 728251, 728246, 728240, and 728235.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI; and, countries of Singapore, New Zealand, India, Australia, Korea, Japan, Korea, China, India, Taiwan, Australia, Turkey, France, South Africa, Spain, Italy, Austria, Belgium, Switzerland, Israel, Netherlands, England, and Brazil.
  • Product Description
    Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. || Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.
  • 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