Events

Recall of Philips Healthcare Ingenuity Core 128 Computed Tomography 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
    Recall
  • Event ID
    72684
  • Event Risk Class
    Class 2
  • Event Number
    Z-0548-2016
  • Event Initiated Date
    2015-10-29
  • Event Date Posted
    2015-12-24
  • 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=142086
  • 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
    Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
  • Action
    On 10/30/2015 the firm sent Customer Information letters to their Consignees.

Device

Philips Healthcare Ingenuity Core 128 Computed Tomography Xray system
  • Model / Serial
    Model No. 728323; S/N: 30016, 32012, 32013, 32016, 32024, 32028, 32033, 32036, 32041, 32046, 32048, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32058, 32059, 32062, 32063, 32064, 32068, 32069, 32070, 32072, 32073, 32074, 32075, 32077, 32078, 32079, 32081, 32082, 32083, 32084, 32086, 32087, 32089, 32092, 32093, 32095, 32097, 32098, 32099, 32100, 32102, 32103, 32104, 32105, 32106, 32108, 32110, 32113, 32114, 32115, 32116, 32119, 32120, 32122, 32123, 32124, 32125, 32128, 32129, 32131, 32132, 32133, 32134, 32135, 32136, 32137, 32138, 32140, 32141, 32145, 32146, 320003, 320006, 320018, 320024, 320029, 320030, 320033, 320037, 320054, 320058, 320069, 320073, 320078, 320079, 320090, 320092, 320099, 320114, 320115, 320123, 320125, 320126, 320128, 320133, 320134, 320138, 320146, 320200, 320201, 320202, 320203, 320204, 320205, 320208, 320212, 320217, 320219, 320220, 320222, 320223, 320224, 320225, 320226, 320228, 320231, 320232, 320239, 320241, 320243, 320246, 320247, 336013, 336015, 336016, 336018, 336027, 336029, 336034, 336046, 336059, 336060, 336064, 336066, 336068, 336071, 336072, 336073, 336075, 336078, 336079, 336080, 336081, 336083, 336084, 336085, 336086, 336087, 336088, 336089, 336091, 336092, 336095, 336097, 336098, 336099, 336105, 336107, 336108, 336110, 336111, 336112, 336113, 336115, 336116, 336117, 336119, 336120, 336121, 336122, 336123, 336126, 336128, 336131, 336132, 336133, 336135, 336137, 336138, 336139, 336140, 336143, 336144, 336145, 336147, 336148, 336150 & 336151.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
  • Product Description
    Ingenuity Core 128 Computed Tomography X-ray system
  • 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