Events

Recall of Device Recall Ingenuity CT 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
    Recall
  • Event ID
    59887
  • Event Risk Class
    Class 2
  • Event Number
    Z-0779-2012
  • Event Initiated Date
    2011-08-29
  • Event Date Posted
    2012-01-17
  • 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=103937
  • 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, brilliance big bore, and ingenuity ct systems, equipped with software version 3.5 beta 2. the non-conformances are due to software errors identified in these device systems.
  • Action
    Philips sent an "URGENT - Medical Device Correction" notification letters to all affected customers via Certified mail on October 19, 2011. The letter describes the referenced software issues; provides instructions to the customers as to what they can do in order to address these issues; and informs the customers of the firm's upcoming software field/correction. The letter states that a Philips representative will be contacting all affected customers to install the necessary software upgrade through a Field Change Order. This will be implemented free of charge. For information or support contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solution Center 1-800-722-9377, option 5.

Device

Device Recall Ingenuity CT system
  • Model / Serial
    Model #728326, Serial Numbers: 300003, 300004, and 300005.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide (USA) including the states of: IN, MI, MO, NY, OH, and OR and the countries of Germany, Israel and Netherlands.
  • Product Description
    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2. || Product Usage: The Brilliance Big Bore 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
    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