Events

Recall of Brilliance iCT Computed Tomography XRay 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
    66601
  • Event Risk Class
    Class 2
  • Event Number
    Z-0335-2014
  • Event Initiated Date
    2013-10-11
  • Event Date Posted
    2013-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122697
  • 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
    If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.
  • Action
    Philips sent an Urgent - Medical Device Correction letter dated October. 11, 2013, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue the use of the footrest extension. Philips also, stated they will replace the old footrest extension with the current one in use. For questions contact your local Philips representative or local Philips Healthcare office.

Device

Brilliance iCT Computed Tomography XRay System,
  • Model / Serial
    Model #728306, Serial #'s: 100016, 100018, 100019, 100020, 100021, 100022, 100023, 100024 and 100025.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) Distribution in the states of DC, GA, IL, IN, NY and OH and the countries: Germany, Israel and Netherlands.
  • Product Description
    Brilliance iCT Computed Tomography X-Ray System, || Product Usage: || The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • 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