Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional…
Medical device recall Z-1874-2016. Published in FDA’s Enforcement Report on Jun 8, 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 Jun 8, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 45 states named
- 424 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?
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Ingenuity Core 128 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.
424 Units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model No. 728323; S/N: 320123 320240 30016 30023 30151 32000 32001 32008 32010 32012 32013 32015 32016 32018 32021 32024 32026 32028 32032 32033 32034 32036 32037 32041 32042 32043 32044 32046 32047 32048 32049 32050 32051 32052 32053…
Every code shown here, 1,995 characters
Model No. 728323; S/N: 320123 320240 30016 30023 30151 32000 32001 32008 32010 32012 32013 32015 32016 32018 32021 32024 32026 32028 32032 32033 32034 32036 32037 32041 32042 32043 32044 32046 32047 32048 32049 32050 32051 32052 32053 32054 32055 32056 32057 32058 32059 32060 32061 32062 32063 32064 32065 32067 32068 32069 32070 32071 32072 32073 32074 32075 32076 32077 32078 32079 32080 32081 32082 32084 32085 32086 32087 32088 32089 32090 32091 32092 32093 32094 32095 32096 32097 32098 32099 32100 32101 32102 32103 32104 32105 32106 32108 32109 32110 32111 32112 32113 32114 32115 32116 32117 32118 32119 32120 32121 32122 32123 32124 32125 32126 32127 32128 32129 32130 32131 32132 32133 32134 32135 32136 32137 32138 32139 32140 32141 32142 32143 32144 32145 32146 32147 32148 32149 32150 32151 32152 32153 32154 32155 32156 32157 32158 32159 32160 32161 32162 32163 32164 32165 32166 32167 32168 52023 52028 52049 52062 122928 320001 320002 320003 320005 320006 320008 320010 320018 320024 320026 320029 320030 320031 320033 320037 320054 320058 320059 320069 320073 320074 320078 320079 320081 320082 320083 320084 320088 320090 320092 320096 320099 320100 320101 320103 320107 320111 320114 320115 320119 320122 320125 320126 320128 320129 320131 320132 320133 320134 320138 320144 320146 320147 320200 320201 320202 320203 320204 320206 320207 320208 320209 320210 320211 320212 320213 320214 320215 320216 320217 320218 320219 320220 320221 320222 320223 320224 320225 320226 320227 320228 320229 320230 320231 320232 320233 320234 320235 320236 320237 320238 320239 320241 320242 320243 320245 320246 320247 320248 320250 320251 320252 320254 320255 320256 320257 320258 320260 320261 320262 320263 320264 320265 320266 320267 320268 320269 333047 336011 336012 336013 336015 336016 336017 336018 336023 336025 336027 336028 336029 336034 336040 336044 336046 336051 336059 336060 336064 336066 336067 336068 336069 336070 336071 336072 336073 336075 336076 336077 336078 336079…
FDA’s list runs to 2,841 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.
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.
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
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 8, 2016.
- FDA classified it on May 31, 2016.
- FDA’s Enforcement Report published it on Jun 8, 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 2,841 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
-
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.