Events

Recall of 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
    69045
  • Event Risk Class
    Class 2
  • Event Number
    Z-2664-2014
  • Event Initiated Date
    2011-09-01
  • Event Date Posted
    2014-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129396
  • 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
    During a field test (a customer external evaluation period), the customer detected a problem in the cirs 4.0 beta 2 software. when using the cirs 4.0 beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. philips has disabled this feature at all sites evaluating 4.0 beta 2 software. philips will issue a software up.
  • Action
    The firm, Philips, sent a Field Safety Notice (FSN 72800534) entitled "URGENT-Medical Device Correction" dated September 1, 2011 via mail on September 6, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to review the following information with all members of your staff who need to be aware of the contents of this communication and retain a copy with the equipment Instructions for Use. A Field Service Engineer will visit each site to install the corrected software. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).

Device

Brilliance 64 and Ingenuity CT
  • Model / Serial
    91003, 30018, 95504, 300004, 300030, 300010, 95130, 95157
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US distribution in OH and countries of: Australia, China, Belgium, Israel, and Sweden.
  • Product Description
    The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • 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