Ingenuity Core
Medical device recall Z-2383-2016. Published in FDA’s Enforcement Report on Aug 17, 2016.
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 Aug 17, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 45 states named in where it went
- 276 Units how much, in FDA’s words
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?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
276 Units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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…
FDA’s list runs to 2,165 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.
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.
The states and territories these words name
45 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- West Virginia
- Wyoming
The words say it went outside the United States too.
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 Apr 29, 2016.
- FDA classified it on Aug 10, 2016.
- FDA’s Enforcement Report published it on Aug 17, 2016.
- FDA terminated it on Jul 2, 2018.
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: Letter.
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 2,165 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.