Events

Recall of Device Recall Philips Healthcare Brilliance iCT/Brilliance iCT SP running software version 4.1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems, 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
    69356
  • Event Risk Class
    Class 2
  • Event Number
    Z-0236-2015
  • Event Initiated Date
    2014-07-31
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130286
  • 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
    It was discovered that a software defect may result in the scanner not terminating the ct scan at the intended location.
  • Action
    Philips Healthcare is directly notifying affected users via letter. In addition, Philips Healthcare has performed the software correction for forward production and plans a Field Correction to fix the defect in the field. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.

Device

Device Recall Philips Healthcare Brilliance iCT/Brilliance iCT SP running software version 4.1
  • Model / Serial
    Software version 4.1.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution
  • Product Description
    Philips Brilliance iCT Computed Tomography X-Ray System || Product Usage: || The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA