Recall of Ingenuity CT XRay System

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Software errors. a number of non-conformances were logged during in-house testing and external validation testing of brilliance 64 and ingenuity ct software version 4.0 beta 2. the non-conformances are due to software errors identified in these device systems.
  • Action
    Philips Healthcare released a 'Field Change Order' (FCO #72800542) on September 15, 2011. Philips sent an URGENT - Medical Device Correction letter dated October 10, 2011, to all affected customers. The letter listed the affected device systems; described the nature of the software problem; and any possible hazard inherent to the situation. The letter was mailed by Philips to their customers on October 27, 2011. The letter provided information telling the customer how to identify the affected products and what action to take. In this instance, the customer was asked to review the Customer Release Notes which were provided to each customer location once the software update was installed. The letter notified the customer that a Philips representative would be installing a software upgrade in order to address the referenced software issues free-of-charge, through a Field Change Order. The letter closes by providing information which all customers in Canada and North America can use to contact the firm through a toll-free telephone number 1-800-722-9377, option 5; enter side ID or follow the prompts. For questions regarding this recall call 440-483-4918.


  • Model / Serial
    Model #728326, 510(k) #KK033326, Serial Numbers: 300010 and 300018.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - USA including Ohio and the countries of Australia, China, Belgium, Israel, and Sweden
  • Product Description
    Ingenuity CT computed Tomography System, Model #728326, 510(k) #K 033326, Serial Numbers: 300010 and 300018. || The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer


  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source