Ingenuity Core 128
Medical device recall Z-1407-2018. Published in FDA’s Enforcement Report on Apr 25, 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 Apr 25, 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
- 591 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?
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
591, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial no: 320309 336076 32104 336092 336150 336100 336228 336089 336095 336100 336116 32125 32123 336117 336120 336126 336139 336131 336149 336142 336150 336152 336161 336166 336150 336182 336203 336211 336217 336220 336221 336289 336283…
Every code shown here, 1,996 characters
Serial no: 320309 336076 32104 336092 336150 336100 336228 336089 336095 336100 336116 32125 32123 336117 336120 336126 336139 336131 336149 336142 336150 336152 336161 336166 336150 336182 336203 336211 336217 336220 336221 336289 336283 336133 336145 336191 30035 345218 52073 336213 320227 320419 336188 32106 336123 336216 32117 32119 32151 66769829 320265 32144 32150 32160 32157 32159 32127 320363 32145 32129 32141 32133 32127 32168 336737 336760 336764 336766 336807 336809 320260 320268 320270 320271 320253 320276 320280 320285 320289 320291 320292 320318 320294 320316 320259 320279 320286 320326 320293 320327 320296 320290 320306 320321 320307 320311 320319 320315 320366 320390 320379 320371 320386 320323 320325 320340 320334 320329 320331 320391 320359 320384 320343 320365 320403 320374 320380 320393 320420 336800 32108 32096 32122 336802 32115 336803 32116 32114 32118 32121 32120 32126 32130 32131 32097 32129 32132 32133 32137 32134 32135 32136 32138 32142 32149 32154 32143 32145 32141 32140 336733 336734 32146 32147 32152 32161 32153 336735 32169 32148 336736 32156 32158 336738 32155 32160 336739 336740 336741 336742 32091 336743 336744 32165 336745 32163 336748 336746 32164 336747 32166 32167 32180 336749 336730 336776 336752 336777 32171 32173 336753 336754 32172 336757 336759 336756 336755 336758 336761 336762 336763 336765 336767 336768 336769 336772 336770 336756 336773 336775 336774 336779 336783 336785 336787 336786 336788 336789 336791 336793 336790 336795 336794 336799 336792 336801 336798 336796 336797 336805 336806 336808 336167 336266 32111 336104 336169 336261 32042 32111 336207 336179 336180 336267 336012 336115 3202694 320235 32179 32170 320201 320200 320220 320206 320221 320222 320262 320231 320237 320236 320254 320269 320245 320417 320275 320281 320303 320301 320288 320302 320370 320310 320313 320317 320344 320412 320367 320444 320381 320399 320411 320438 320429 320424 320358 320212 336096 320229 320266 336205 32103 336083 336115 336151…
FDA’s list runs to 4,053 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 - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
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 Feb 8, 2018.
- FDA classified it on Apr 17, 2018.
- FDA’s Enforcement Report published it on Apr 25, 2018.
- FDA terminated it on Apr 9, 2020.
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 4,053 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.