Philips Ingenuity Core computed tomography x-ray system
Medical device recall Z-0519-2018. Published in FDA’s Enforcement Report on Feb 14, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 14, 2018. Copied from openFDA on Oct 20, 2026.
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Numerous issues related to software Brilliance iCT 4.1.6 software version.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips Ingenuity Core computed tomography x-ray system
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Ingenuity Core 728321 SN# - 310003 310002 310001 310096 310023 310017 310022 310071 310105 310026 310032 310042 310039 310064 310059 310052 333002 310055 310069 310070 310088 310087 310111 310090 310116 310107 310009 310121 310081 333009…
Every code shown here, 2,000 characters
Ingenuity Core 728321 SN# - 310003 310002 310001 310096 310023 310017 310022 310071 310105 310026 310032 310042 310039 310064 310059 310052 333002 310055 310069 310070 310088 310087 310111 310090 310116 310107 310009 310121 310081 333009 310113 310119 333015 310129 52013 333005 333080 333064 52015 310133 310134 310143 310141 310159 310135 310151 333041 310157 310149 333030 310170 333019 310160 30041 52012 333014 52022 333031 52008 310203 52000 333018 333061 52010 310204 333021 52007 333076 52014 52018 52019 52021 333093 333052 52045 52040 52026 333045 52024 52020 333044 52032 333051 52033 52038 52041 333037 333042 52042 310211 333117 333043 52039 333056 310234 310212 310214 333053 31001 333055 52030 310207 52043 52052 310205 52031 52047 333046 52061 52059 333066 52057 333060 333059 52053 333062 52058 52055 52054 52025 310215 52029 52037 52034 52035 52036 52046 333054 333072 310223 333065 333075 52056 52027 333067 310220 310206 310236 310208 52048 333085 333073 333101 52069 333049 52064 333069 333087 52044 52065 333078 52079 333070 310210 52072 333074 52067 52068 333088 52075 310213 333063 333048 333050 52063 310292 52071 333068 310227 310217 333077 333086 333145 310209 333091 333082 333096 33084 333110 52070 310228 310241 52078 333116 333081 333094 310243 310232 310288 52076 310281 310254 310230 333090 333079 310226 310219 310225 310224 310221 52050 310216 310252 333083 52077 310238 310222 310294 310249 310229 333121 310250 310275 333112 310247 333097 310218 310257 310296 310304 310235 310255 310237 310246 310240 333071 310286 310248 310260 333089 52081 333095 333099 333098 310233 310231 310259 310283 310295 310239 310279 310276 310289 333114 310245 310291 310258 310293 310284 333109 333115 310297 310256 310308 310270 310264 333103 333136 310242 310287 310316 310273 310262 310253 310282 310271 310299 310274 310265 310311 310280 310269 333100 310277 310272 310261 310267 333105 310263 310278 310300 333119 310285 310266 310290 333102 333125 310301 333135 333092 333104…
FDA’s list runs to 2,413 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
26 US Govt accounts
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 6, 2017.
- FDA classified it on Feb 4, 2018.
- FDA’s Enforcement Report published it on Feb 14, 2018.
- FDA terminated it on Jul 2, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Medical Systems (Cleveland) Inc, of Cleveland, OH.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,413 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.