Ingenuity Core
Medical device recall Z-1406-2018. 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
- 281 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 - Model no. 728321, 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.
281, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. : 310204 310216 310264 52004 333094 52084 333060 333076 52069 333103 333110 333112 333064 52066 333142 310231 333096 333149 52053 333061 333062 333136 310383 52077 333093 310219 52065 310226 333092 333107 333108 310222 310206…
Every code shown here, 1,945 characters
Serial No. : 310204 310216 310264 52004 333094 52084 333060 333076 52069 333103 333110 333112 333064 52066 333142 310231 333096 333149 52053 333061 333062 333136 310383 52077 333093 310219 52065 310226 333092 333107 333108 310222 310206 310207 310225 310219 310226 310238 310317 310324 310330 310365 310337 310224 333072 333067 333074 333070 52065 333086 333085 333078 333079 333156 52075 52078 333088 33084 333083 333089 52083 333099 333098 333104 333101 52079 333106 333111 52082 333113 333123 333122 333121 333118 333124 333127 333125 333141 333147 333134 333137 333139 333155 333164 52052 333097 52014 333090 333132 333159 333073 52070 333080 333081 333087 333071 333126 333120 333140 333145 333146 333150 333151 333154 333082 52012 333056 333095 333117 310209 310245 333091 333109 333115 333105 333129 333138 333144 310214 52067 310318 52068 333066 333075 333131 333133 333163 52080 333114 333116 52081 52061 310239 310233 310366 310380 52056 52059 52063 52072 52071 52076 52064 333063 333068 333148 333152 333130 333059 333077 310347 333065 333119 52057 52058 52055 333102 333143 333153 310207 333100 333135 52054 310203 310299 310278 310277 310220 310319 310208 310213 310212 310217 310215 310274 310253 310267 310262 310241 310228 310258 310285 310249 310255 310294 310266 310243 310235 310363 310256 310289 310254 310292 310290 310283 310281 310301 310261 310271 310296 310227 310234 310259 310242 310286 310280 310232 310316 310287 310270 310273 310304 310282 310246 310269 310297 310303 310250 310295 310272 310260 310237 310221 310247 310229 310311 310305 310307 310308 310310 310309 310331 310322 310321 310364 310329 310335 310346 310334 310345 310350 310336 310344 310367 310279 310244 310298 310306 310275 310276 310284 310291 310288 310293 333071 310205 310210 310218 310300 310223 310265 310230 310236 310248 310257 310252 310240 310268 310263 310327 310251 310338 310343 310332 310016 310323 333079 310225 333078 336084 310315
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.”
- 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.