Events

Recall of Device Recall Brilliance CT System, Big Bore Configuration.

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
    36685
  • Event Risk Class
    Class 2
  • Event Number
    Z-0636-2007
  • Event Initiated Date
    2006-10-02
  • Event Date Posted
    2007-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49169
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Two conditions have been identified with the philips medical system brilliance bore ,version 2.2.1 tumor localization, that may lead the user to misinterpret the displayed data.
  • Action
    Customer advisory notification letters dated 10/4/06 and 10/25/06 were sent to consignees providing short term work around instructions. Software modifications installed by the recalling firm will follow as the long term correction.

Device

Device Recall Brilliance CT System, Big Bore Configuration.
  • Model / Serial
    Serial numbers 7009, 7056, 7060, 7066, 7069, 7072, 7079, 7088, 7111, 7112, 7113, 7114, 7117, 7118, 7119, 7121, 7125.
  • Product Classification
    Radiology Devices
  • Distribution
    Class II Recall-Nationwide Distribution-USA including states of KY, MD, TX, RI, NJ, MA, LA, VA, PA, SC, CA, OH, and FL.
  • Product Description
    Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
  • 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