Brilliance iCT
Medical device recall Z-2381-2016. 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
- 335 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 versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
335 Units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Brilliance iCT Model No. 728306 S/N:85071 85072 100150 100349 100695 100715 100716 100719 100721 100723 100724 100725 100726 100727 100728 100105 100123 100130 100132 100141 100146 100159 100328 100375 100378 100473 100700 100703 100709…
Every code shown here, 1,995 characters
Brilliance iCT Model No. 728306 S/N:85071 85072 100150 100349 100695 100715 100716 100719 100721 100723 100724 100725 100726 100727 100728 100105 100123 100130 100132 100141 100146 100159 100328 100375 100378 100473 100700 100703 100709 100710 100711 100712 100713 100717 100720 100162 85003 85004 85010 85012 85013 85014 85015 85016 85017 85018 85019 85020 85021 85022 85023 85024 85025 85026 85027 85028 85029 85030 85031 85032 85033 85034 85035 85036 85037 85038 85039 85040 85041 85042 85043 85044 85045 85046 85047 85048 85049 85050 85051 85052 85053 85054 85055 85056 85057 85058 85059 85060 85061 85062 85063 85064 85065 85066 85067 85068 85069 85070 100016 100018 100019 100022 100024 100025 100037 100038 100040 100044 100048 100049 100050 100051 100053 100054 100058 100062 100064 100065 100070 100072 100082 100084 100091 100093 100094 100099 100101 100103 100111 100113 100114 100115 100119 100122 100125 100131 100133 100134 100135 100140 100144 100149 100153 100161 100165 100169 100170 100178 100180 100181 100184 100185 100190 100191 100192 100193 100195 100200 100214 100215 100217 100221 100222 100228 100231 100236 100243 100244 100247 100260 100270 100271 100273 100274 100278 100280 100281 100289 100299 100302 100304 100308 100309 100310 100314 100318 100325 100329 100331 100335 100343 100346 100350 100351 100356 100360 100365 100368 100370 100372 100373 100374 100393 100396 100398 100399 100400 100402 100405 100406 100408 100411 100416 100423 100436 100441 100446 100449 100450 100452 100453 100454 100458 100461 100462 100463 100464 100465 100466 100469 100472 100483 100490 100491 100493 100494 100498 100503 100506 100507 100508 100509 100511 100512 100513 100517 100518 100520 100521 100522 100600 100601 100602 100603 100604 100605 100606 100607 100608 100609 100610 100611 100612 100613 100614 100615 100616 100617 100618 100619 100620 100621 100622 100623 100624 100625 100626 100627 100628 100629 100630 100631 100632 100633 100634 100635 100636 100637 100638…
FDA’s list runs to 2,477 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 2,477 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.