Events

Recall of Device Recall XRay, Tomography, Computed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America Corporation.

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
    78144
  • Event Risk Class
    Class 2
  • Event Number
    Z-0016-2018
  • Event Initiated Date
    2017-01-18
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158767
  • 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 bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. there is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. the operator may choose to rescan the patient.
  • Action
    Philips will bring defect into compliance: 1. Will issue a customer notification letter. 2. Will provide a software update, at no cost to the customer. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. You will implement this CAP by April 30, 2018. If you need any further information or support concerning this issue, please contact your local Philips representative or the Customer Care Solutions Center at 1-800-722 9377. .

Device

Device Recall XRay, Tomography, Computed
  • Model / Serial
    Software version 4.16
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution
  • Product Description
    Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed || These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA