Events

Recall of Ingenuity Core Computed Tomography Xray systems

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
    72282
  • Event Risk Class
    Class 2
  • Event Number
    Z-0175-2016
  • Event Initiated Date
    2015-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140469
  • 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
    The firm discovered ring/dot artifact due to x-ray measurement error.
  • Action
    On 9-23-2015 the firm sent URGENT Field Safety Notices to their customers. The letter identified the products, problem, and actions to be taken by the customers.

Device

Ingenuity Core Computed Tomography Xray systems
  • Model / Serial
    Model No. 728321; S/N: 52000, 52001, 52002, 52003, 52004, 52006, 52009, 52011, 52012, 52015, 52016, 52017, 52020, 52022, 52025, 52027, 52029, 310116, 310150, 310152, 310153, 310154, 310155, 310156, 310158, 310161, 310162, 310163, 310164, 310166, 310171, 333013, 333026, 333027, 333028, 333032, 333035, 333036, 333037, 333038, 333039 &333042.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
  • Product Description
    Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA