Brilliance iCT
Medical device recall Z-0403-2018. Published in FDA’s Enforcement Report on Jan 31, 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 Jan 31, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 559 total 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?
Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
559 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Brilliance iCT 4.1.6 version. Brilliance iCT - Model 728306 Codes: 100688 85025 100790 100490 100667 85054 100408 100604 85031 100703 100411 100114 100314 100278 100349 100654 100406 100452 100453 100404 100242 100115 100383 100189 100347…
Every code shown here, 1,997 characters
Brilliance iCT 4.1.6 version. Brilliance iCT - Model 728306 Codes: 100688 85025 100790 100490 100667 85054 100408 100604 85031 100703 100411 100114 100314 100278 100349 100654 100406 100452 100453 100404 100242 100115 100383 100189 100347 100348 100450 100748 100507 100181 100469 200005 100638 100195 100101 100440 100223 100616 100619 100134 100304 100656 100436 100773 100130 100621 100113 85055 100600 100180 85060 100704 100750 85041 100737 100231 100615 100612 100393 100643 100356 100134 100722 85048 85059 100680 85016 100521 100678 100726 85052 100683 100760 100691 100635 100738 85057 100614 100758 100687 100138 100733 100707 100706 100701 100191 85062 100247 100318 85002 85023 100712 85058 85026 85037 85027 100310 85068 100512 100734 85051 100161 100628 100740 85035 100709 100775 100669 100769 100768 100800 100792 100637 100692 100639 100735 100756 100776 85069 100749 100519 100716 100732 100640 100622 100662 100132 85053 85040 100766 85072 100767 100713 100717 100772 85067 100763 85070 85036 100711 85064 100644 100697 85021 100757 85022 100627 100771 100651 100765 100746 85020 100617 85044 100755 85015 85066 100677 100602 100518 100752 100696 100672 100666 85042 100624 85028 100642 100636 85045 85047 85046 100659 85065 85063 85061 85030 100698 100710 100727 100736 85075 100745 100762 100751 85071 100796 100265 100787 100783 100784 100795 100778 100780 100798 100786 100234 100377 100799 100781 100797 100785 100230 85032 100730 100770 100153 100373 100400 100402 100398 100405 100509 100331 100652 100608 100462 100694 100742 100682 100092 100646 100328 100051 100123 100623 100144 85038 100372 100044 100054 100378 100160 100322 100060 100317 100657 100665 100684 100754 100184 100705 100720 100645 85029 85050 100351 85077 100686 100739 100018 85076 85079 100087 100648 100650 100673 200004 85003 85004 85010 100721 100708 100199 85039 100145 100032 100064 100610 100653 100084 100385 100099 100146 100517 100603 100728 85014 100217 100214 100744 100498 100058 100632…
FDA’s list runs to 3,461 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, including US nationwide.
These words name no state.
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 Jul 11, 2017.
- FDA classified it on Jan 23, 2018.
- FDA’s Enforcement Report published it on Jan 31, 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: 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 3,461 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.