Events

Recall of Philips Healthcare Ingenuity CT CT Xray system

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
    71926
  • Event Risk Class
    Class 2
  • Event Number
    Z-0408-2016
  • Event Initiated Date
    2015-04-14
  • 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=139378
  • 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 scans with specific protocol steps, the software unexpectedly sets the axial ( 2 axis ) scan length to a different length than the user set in the plan.
  • Action
    Philips Healthcare Planned Action: 1. Philips Healthcare will contact customers and initiate a software update to correct the defect. 2. Philips Healthcare engineers will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. 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. Philips Healthcare will implement this CAP by April 1, 2016. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.

Device

Philips Healthcare Ingenuity CT CT Xray system
  • Model / Serial
    728326
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mayanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Republic of Korea, Reunion, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tanzania, Tunisia, Turkey, United Arab Emirates, Uzbekstan and Vietnam.
  • Product Description
    Philips Healthcare Ingenuity CT Computed Tomography X-ray system
  • 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