Philips Ingenuity CT computed tomography x-ray system
Medical device recall Z-0521-2018. 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 CT 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# - 4001 4016 9056 9067 9071 9074 9099 9112 9134 9194 9213 9235 9251 9263 9268 9269 9272 9280 9367 9515 9515 9521 9529 9538 9541 9548 9549 9554 9559 9561 9573 9574 9579 9584 9600 9607 9614 9618 9625 9631 9633…
Every code shown here, 1,994 characters
Ingenuity Core 128 - 728323 SN# - 4001 4016 9056 9067 9071 9074 9099 9112 9134 9194 9213 9235 9251 9263 9268 9269 9272 9280 9367 9515 9515 9521 9529 9538 9541 9548 9549 9554 9559 9561 9573 9574 9579 9584 9600 9607 9614 9618 9625 9631 9633 9638 9640 9646 9649 9653 9656 9659 9667 9670 9678 9686 9688 9689 9703 9707 9711 9720 9738 9740 9755 9761 9763 9781 9782 9788 9802 9805 9808 9811 9822 9833 9837 9838 9859 9862 9864 9867 9876 9890 9898 9901 9909 9910 9917 9920 9922 9923 9927 9930 9933 9950 9969 9983 9989 9993 9996 9997 10012 10014 10021 10024 10032 10042 10046 10047 10050 10051 10060 10069 10072 10076 10077 10092 10099 10102 10106 10121 10137 10150 10151 10173 10179 10180 10193 10200 10203 10206 10206 10207 10208 10213 10216 10221 10247 10250 10255 10288 10299 10302 10307 10310 10316 10351 10379 10391 10394 10418 10422 10446 10470 10473 10474 10503 10514 10519 10540 10561 10566 10574 10580 10599 10605 10610 10659 10671 10698 10708 10733 10743 10773 29002 29005 29014 29025 29034 29049 29056 29057 29107 29115 29138 90098 90106 90124 90131 90154 90158 90205 90213 90224 91003 95022 95024 95036 95130 95157 95191 95197 95204 95213 95222 95223 95236 95239 95244 95258 95259 95261 95263 95280 95313 95341 95343 95345 95349 95351 95364 95374 95387 95399 95401 95409 95410 95411 95439 95441 95443 95462 95475 95489 95496 95504 95507 95512 95523 95524 95526 95538 95542 95551 95553 95563 95567 95593 95597 95598 95599 95614 95616 95619 95656 95667 95668 95688 95691 95707 95811 6003368 6003844 6003941 310019 310321 333130 310314 333132 310306 310307 310298 310302 310244 310324 310310 310309 310305 310268 333126 310317 52080 333149 333120 310331 333127 310325 333131 310319 52084 310322 333150 333151 52082 310251 310327 310332 310338 310326 333137 52083 333140 310335 333139 333138 333144 333146 310323 333141 310340 310339 333142 333147 333143 310328 310329 333148 310334 333153 333154 310347 310330 310348 310354 310356 310353 310349 310355 310352 333159 333001 310094 310346 310363…
FDA’s list runs to 5,217 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 5,217 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.