Events

Recall of Ingenuity Core Model No. 728321

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
    74131
  • Event Risk Class
    Class 2
  • Event Number
    Z-2383-2016
  • Event Initiated Date
    2016-04-29
  • 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=146402
  • 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 issues in software versions v4.1.3/4.1.4/4.1.5 in the philips brilliance 64 and ingenuity ct products that could affect the performance of the equipment.
  • Action
    The customers will be sent a letter with information about, what the problems are and under what circumstances they may occur, the actions customers can take to minimize the effect of the problem and the actions planned by Philips to correct the problem. To correct these issues, a Philips field service representative will install a software update on the affected systems. Reference field change order (FCO) 72800652.

Device

Ingenuity Core Model No. 728321
  • Model / Serial
    Ingenuity Core Model No. 728321 S/N:31001 52030 52031 52044 52050 310292 333064 52000 52012 52015 52018 52020 52022 52063 310001 310022 310023 310026 310032 310039 310096 310105 310133 310135 310157 310160 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 310236 310237 310238 310239 310240 310241 310242 310243 310245 310246 310247 310248 310249 310250 310252 310253 310254 310255 310256 310257 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 310287 310288 310289 310290 310291 333002 333005 333010 333015 333018 333021 333042 333043 333051 333060 333061 333106 333107 333108 333109 333110 333112 333114 333115 333116 333117 333121 52035 333068 33084 52007 52008 52010 52013 52014 52019 52021 52024 52025 52026 52027 52029 52032 52033 52034 52036 52037 52038 52039 52040 52041 52042 52043 52045 52046 52047 52048 52052 52053 52054 52055 52056 52057 52058 52059 52061 52064 52065 52067 52068 52069 52070 52071 52072 52075 52076 52077 52078 52079 132164 132465 310002 310003 310009 310017 310042 310052 310054 310055 310059 310064 310069 310070 310071 310081 310087 310088 310090 310098 310107 310111 310113 310119 310121 310129 310134 310141 310143 310149 310151 310159 310170 310203 310204 310205 310206 310207 310208 310235 310293 310294 310295 310296 310297 310299 310300 310301 310304 310308 333009 333014 333019 333030 333031 333037 333044 333045 333046 333048 333049 333050 333052 333053 333054 333055 333056 333059 333062 333063 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 333122 333123 333124 52004 52073 52074 52080 52084 310019 310125 310150 310244 310268 310298 310302 310305 310306 310307 310309 310310 333041 333120 333126 333127 333130 333131 333132
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was shipped to the following states: 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 Model No. 728321; 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