Ingenia Ambition S
Medical device recall Z-1850-2024. 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
- 328 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 Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359
328 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: (1) 782139 (01)00884838108639(21); (2) 782133 N/A; (3) 782108 (01)00884838098343(21); (4) 781359 (01)00884838090057(21) Serial Numbers: Serial Number 48016 48053 48126 48003 48136 48285 48144 48020 48030 48124 48155 48191 48216…
Every code shown here, 2,000 characters
UDI-DI: (1) 782139 (01)00884838108639(21); (2) 782133 N/A; (3) 782108 (01)00884838098343(21); (4) 781359 (01)00884838090057(21) Serial Numbers: Serial Number 48016 48053 48126 48003 48136 48285 48144 48020 48030 48124 48155 48191 48216 48218 48245 48300 48183 48186 48187 48222 48225 48234 48240 48241 48249 48269 48278 48284 48288 48293 48294 48299 48304 48313 48317 48326 48331 48051 48223 48207 48028 48031 48049 48050 48131 48134 48154 48160 48242 48254 48219 48000 48004 48005 48009 48019 48032 48132 48145 48224 48244 48040 48122 48039 48022 48152 48173 48012 48014 48036 48037 48044 48127 48151 48158 48174 48184 48043 48046 48047 48055 48128 48129 48153 48178 48180 48190 48192 48194 48226 48275 48181 48198 48199 48200 48023 48033 48045 48001 48038 48167 48185 48196 48236 48238 48239 48034 48276 48010 48170 48035 48172 48027 48248 48146 48147 48148 48163 48164 48165 48169 48182 48188 48271 48291 48297 48302 48303 48308 48309 48310 48329 48018 48283 48177 48011 48017 48056 48250 48272 48253 48268 48013 48015 48052 48112 48120 48130 48162 48166 48171 48179 48214 48217 48233 48237 48243 48252 48273 48274 48286 48287 48314 48026 48322 48133 48316 48558 48572 48566 48581 48592 48652 48800 48893 48544 48506 48520 48521 48534 48551 48712 48714 48715 48810 48813 48833 48883 48885 48538 48539 48602 48613 48650 48501 48502 48507 48514 48530 48540 48568 48569 48577 48579 48580 48590 48591 48614 48620 48629 48632 48638 48641 48503 48606 48660 48529 48609 48622 48541 48549 48616 48504 48508 48513 48524 48536 48537 48555 48560 48571 48573 48585 48593 48594 48597 48600 48522 48561 48564 48668 48726 48519 48532 48533 48505 48510 48567 48604 48515 48584 48512 48582 48647 48850 48610 48615 48500 48523 48535 48546 48552 48554 48562 48575 48578 48586 48637 48645 48648 48656 48525 48526 27500 27502 27504 27505 27506 27507 27508 27509 27511 27512 27514 27515 27516 27517 27518 27519 27520 27522 27523 27524 27525 27526 27527 27528 27529 27530 27531 27532 27533 27535 27536 27539 27541 27542…
FDA’s list runs to 2,119 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 2,119 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.