Ingenia 3.0T CX
Medical device recall Z-1849-2024. Published in FDA’s Enforcement Report on May 29, 2024.
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 May 29, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 350 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?
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital’s technical room, resulting in Smoke and/or fire
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
350 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: (1) (01)00884838098312(21); (2) (01)00884838068452(21) Serial Number 78121 78150 78157 78096 78208 78094 78012 78074 78154 78161 78170 78171 78172 78173 78182 78183 78189 78190 78196 78198 78205 78210 78212 78213 78216 78218 78221…
Every code shown here, 1,997 characters
UDI-DI: (1) (01)00884838098312(21); (2) (01)00884838068452(21) Serial Number 78121 78150 78157 78096 78208 78094 78012 78074 78154 78161 78170 78171 78172 78173 78182 78183 78189 78190 78196 78198 78205 78210 78212 78213 78216 78218 78221 78225 78233 78235 78238 78240 78241 78242 78243 78244 78250 78251 78252 78253 78256 78257 78262 78263 78265 78266 78267 78268 78269 78270 78271 78272 78273 78279 78280 78281 78282 78283 78284 78288 78289 78291 78292 78293 78294 78295 78296 78301 78305 78306 78307 78308 78309 78310 78312 78313 78314 78316 78317 78319 78320 78321 78322 78323 78327 78328 78329 78330 78332 78333 78334 78335 78338 78339 78340 78341 78342 78343 78345 78346 78347 78352 78353 78354 78356 78357 78358 78359 78360 78361 78362 78363 78364 78366 78368 78370 78374 78375 78376 78377 78386 78078 78080 78224 78098 78003 78017 78065 78070 78076 78081 78087 78097 78099 78101 78104 78107 78126 78149 78151 78181 78206 78219 78264 23032 78063 78064 78106 78187 78000 78005 78007 78009 78010 78015 78016 78018 78019 78021 78023 78025 78027 78029 78031 78032 78033 78035 78038 78039 78040 78042 78043 78045 78048 78049 78050 78051 78062 78067 78068 78072 78082 78083 78084 78088 78089 78091 78095 78100 78109 78111 78113 78114 78115 78117 78127 78129 78132 78133 78139 78140 78145 78147 78148 78155 78199 78203 78207 78214 78222 78223 78004 78008 78053 78011 78013 78014 78028 78034 78044 78046 78047 78058 78060 78066 78071 78073 78075 78077 78086 78092 78102 78103 78110 78112 78118 78120 78122 78123 78128 78135 78137 78138 78141 78142 78158 78162 78164 78166 78167 78175 78180 78186 78188 78193 78194 78195 78197 78201 78202 78209 78215 78217 78227 78229 78232 78234 78239 78247 78254 78255 78259 78260 78261 78277 78286 78287 78290 78297 78298 78299 78324 78326 78336 78337 78030 78036 78059 78156 78249 78026 78022 78516 78517 78518 78519 78521 78522 78523 78524 78525 78526 78527 78528 78529 78530 78531 78536 78537 78539 78545 78546 78547 78548 78549 78550 78551 78553 78554 78556…
FDA’s list runs to 2,170 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 - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 May 3, 2024.
- FDA classified it on May 17, 2024.
- FDA’s Enforcement Report published it on May 29, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America Llc, of Cambridge, MA.
- 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 2,170 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.