Events

Recall of Device Recall Brilliance 64 and Ingenuity CT

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
    61363
  • Event Risk Class
    Class 2
  • Event Number
    Z-1285-2012
  • Event Initiated Date
    2012-02-17
  • Event Date Posted
    2012-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107919
  • 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
    A number of non-conformances were identified during internal and external validation testing of the brilliance 64 and ingenuity ct systems with software version beta 3 (version 4.0.0.Xx368).
  • Action
    Philips Healthcare sent an Urgent Medical Device Correction letter dated February 17, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of the contents in the communication. Customers were asked to retain a copy of the communication with the equipment instruction for Use. For further information or support concerning this issue, customers should contact their local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center at 1-800-722-9377, option 5. For questions regarding this recall call 440-483-7000.

Device

Device Recall Brilliance 64 and Ingenuity CT
  • Model / Serial
    System Code # 728231, Serial # 91003, 95130, 95157, 95504 & 300030; System Code # 728326, Serial # 300010 & 300018.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including OH and the following countries: Australia, China, Belgium, Israel & Sweden.
  • Product Description
    Whole body Computed Tomography X-Ray System (Brilliance 64 and Ingenuity CT), Brilliance 64 M/N 728231, Ingenuity CT M/N 728326, Dist. By Philips Medical Systems, Cleveland, OH
  • 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