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
    73961
  • Event Risk Class
    Class 2
  • Event Number
    Z-1873-2016
  • Event Initiated Date
    2016-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145694
  • 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 became aware of a problem where the system may not map varian drive after ct user logout/login.
  • Action
    The firm sent a Customer Information letters dated March 8, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).

Device

Ingenuity Core Computed Tomography Xray Systems
  • Model / Serial
    Model No. 728321; S/N: 310135 310257 52035 333068 31001 33084 52000 52007 52008 52010 52012 52013 52014 52015 52018 52019 52020 52021 52022 52024 52025 52026 52027 52029 52030 52031 52032 52033 52034 52036 52037 52038 52039 52040 52041 52042 52043 52044 52045 52046 52047 52048 52050 52052 52053 52054 52055 52056 52057 52058 52059 52061 52063 52064 52065 52066 52067 52068 52069 52070 52071 52072 52075 52076 52077 52078 52079 52080 52081 132164 132465 300141 310001 310002 310003 310009 310017 310022 310023 310026 310032 310039 310042 310052 310054 310055 310059 310064 310069 310070 310071 310081 310087 310088 310090 310096 310098 310107 310111 310113 310119 310121 310129 310133 310134 310141 310143 310149 310151 310157 310159 310160 310170 310203 310204 310205 310206 310207 310208 310209 310210 310211 310212 310213 310214 310215 310216 310217 310218 310219 310220 310221 310222 310223 310224 310225 310226 310227 310228 310229 310230 310231 310232 310233 310234 310235 310236 310237 310238 310239 310240 310241 310242 310243 310245 310246 310247 310248 310249 310250 310252 310253 310254 310255 310256 310258 310259 310260 310261 310262 310263 310264 310265 310266 310267 310269 310270 310271 310272 310273 310274 310275 310276 310277 310278 310279 310280 310281 310282 310283 310284 310285 310286 310287 310288 310289 310290 310291 310292 310293 310294 310295 310296 310297 310299 310300 310301 310304 310308 333002 333004 333005 333009 333010 333014 333015 333018 333019 333021 333030 333031 333037 333042 333043 333044 333045 333046 333048 333049 333050 333051 333052 333053 333054 333055 333056 333059 333060 333061 333062 333063 333064 333065 333066 333067 333069 333070 333071 333072 333073 333074 333075 333076 333077 333078 333079 333080 333081 333082 333083 333085 333086 333087 333088 333089 333090 333091 333092 333093 333094 333095 333096 333097 333098 333099 333100 333101 333102 333103 333104 333105 333106 333107 333108 333109 333110 333111 333112 333113 333114 333115 333116 333117 333118 333119 333120 333121 333122 333123 333124.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
  • Product Description
    Ingenuity Core Computed Tomography X-ray Systems, || Product Usage: || Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
  • 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