Philips Ingenuity Core 128 computed tomography x-ray system
Medical device recall Z-0520-2018. 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 128 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 128 - 728323 SN# - 320002 320001 320006 320003 320005 320010 320008 320030 320037 320019 320033 320018 320024 320029 320026 320031 320059 320054 320058 320074 320081 336207 320079 320078 320069 320080 320073 320115 320092…
Every code shown here, 1,994 characters
Ingenuity Core 128 - 728323 SN# - 320002 320001 320006 320003 320005 320010 320008 320030 320037 320019 320033 320018 320024 320029 320026 320031 320059 320054 320058 320074 320081 336207 320079 320078 320069 320080 320073 320115 320092 320090 320083 320084 320082 320096 320133 320103 320100 320101 336015 320138 32021 320107 320111 320132 320126 320114 336016 320248 320123 336011 320099 320122 336018 320134 320215 320146 320119 336013 320125 320131 32058 32013 320129 32085 320147 336012 320128 336017 336025 32042 336023 32012 320206 336034 320144 32018 336029 32016 336028 320227 32026 32032 32099 320214 32015 32054 336046 336070 32024 336027 32010 336103 32059 336069 32055 336040 32033 320204 32037 32043 32047 32034 32036 32049 32041 336072 336075 336044 32044 32070 32069 32050 32091 32089 32092 32072 32048 336067 32052 32102 32062 32046 32074 32056 32073 336091 336071 336059 320233 336064 336068 32057 336102 32053 32060 32071 336083 32064 32081 32106 32079 32068 32132 336051 32063 336060 32100 32075 336076 32051 32101 336144 336148 336085 336066 320230 32082 336077 32077 32090 336118 336086 32094 336080 336078 32078 32087 320217 32080 32001 32065 32088 320232 320213 336090 32067 336082 32160 32122 32130 336088 32098 32108 32093 320250 336092 336093 336073 32084 320220 32111 336087 32109 32105 336097 336098 32104 32103 32096 32121 336094 336079 32086 336106 336099 336089 32095 336096 32113 32112 32110 320210 336105 336081 32120 336130 32114 32119 32159 32118 32156 336095 320241 336104 336108 32143 336115 336129 32116 336140 336122 336111 336127 32135 336107 32168 320236 336100 320222 320221 32126 32129 32097 320216 320231 320201 320200 320207 336109 336141 320202 320229 32115 336110 32117 320203 336123 336116 336132 320283 336119 336151 32124 336131 336138 320209 32123 336139 336112 336124 320212 320208 320218 336128 336101 32140 320243 32133 32141 320271 336214 336133 32151 32146 336137 320239 320219 320237 320267 32125 336120 336126 320235 32131 32134 32152…
FDA’s list runs to 4,283 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 4,283 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.