Events

Recall of Device Recall The Brilliance 64 and Ingenuity CT Computed Tomography Scanners

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
    62641
  • Event Risk Class
    Class 2
  • Event Number
    Z-2223-2012
  • Event Initiated Date
    2012-07-18
  • Event Date Posted
    2012-08-17
  • 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=111235
  • 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
    1. the current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for ct brain perfusion scanning, which previous versions did. however, the current version does have the dose check (nema xr-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable dose check after ente.
  • Action
    Philips Healthcare sent an URGENT - Medical Device Correction letter date July 18, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Phillips will be installing a software update version 4.0.0xx516. A Philips Service Engineer will contact the customer for implementation of the software update on the affected systems free of charge. For further information or support concerning this issue, customers may contact their local Philips representatives or Philips Healthcare office. For North America and Canada, they may also contact the Customer Care Solutions Center (1-800-722-9377, option 5) For questions regarding this recall call 440-483-7000.

Device

Device Recall The Brilliance 64 and Ingenuity CT Computed Tomography Scanners
  • Model / Serial
    System Code # 728231, Serial #s: 91003, 95157, 9654, 95130, and 95504  System Code # 728326, Serial #s: 300010, 300030, and 300018
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including IN and OH, also, the countries of Australia, Belgium, China, Israel, and Sweden
  • Product Description
    The Brilliance 64 and Ingenuity CT are whole body 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. This device 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 Road, Cleveland OH 44143-2131
  • Source
    USFDA