Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a…
Medical device recall Z-1851-2024. 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
- 509 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 X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356
509 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: (1) 782138 (01)00884838108622(21); (2) 782109 (01)00884838098350(21); (3) 781356 (01)00884838090040(21); Serial Number 47194 47040 47092 47091 47048 47195 47345 47361 47050 47209 47246 47247 47293 47254 47275 47019 47049 47200…
Every code shown here, 1,999 characters
UDI-DI: (1) 782138 (01)00884838108622(21); (2) 782109 (01)00884838098350(21); (3) 781356 (01)00884838090040(21); Serial Number 47194 47040 47092 47091 47048 47195 47345 47361 47050 47209 47246 47247 47293 47254 47275 47019 47049 47200 47356 47357 47197 47270 47013 47014 47015 47053 47065 47082 47099 47268 47274 47000 47002 47003 47017 47020 47024 47035 47047 47056 47058 47074 47078 47089 47097 47192 47225 47337 47226 47227 47341 47307 47364 47365 47372 47284 47350 47057 47075 47081 47088 47174 47175 47188 47193 47288 47052 47059 47072 47085 47184 47187 47211 47252 47262 47304 47328 47342 47384 47064 47244 47219 47220 47298 47094 47329 47096 47207 47283 47190 47264 47309 47034 47202 47315 47332 47367 47385 47016 47269 47382 47352 47012 47021 47221 47276 47297 47313 47314 47271 47281 47001 47032 47041 47248 47255 47258 47301 47311 47272 47306 47009 47023 47030 47080 47083 47189 47215 47222 47230 47231 47242 47245 47286 47299 47302 47310 47312 47004 47006 47007 47011 47018 47022 47025 47026 47027 47028 47029 47033 47037 47038 47039 47043 47044 47045 47051 47054 47060 47061 47062 47063 47066 47067 47068 47070 47071 47084 47090 47093 47095 47098 47177 47183 47185 47196 47198 47199 47203 47204 47205 47206 47208 47210 47216 47233 47237 47251 47253 47260 47278 47279 47280 47282 47289 47290 47291 47292 47294 47303 47305 47316 47322 47323 47324 47325 47330 47331 47333 47335 47336 47338 47339 47340 47344 47346 47347 47348 47351 47353 47370 47371 47377 47378 47380 47387 47173 47077 47657 47866 47531 47540 47878 47612 47717 47518 47519 47523 47526 47552 47555 47573 47584 47839 47565 47644 47742 47585 47582 47885 47669 47748 47755 47507 47508 47505 47570 47610 47500 47527 47529 47545 47640 47725 47778 47855 47532 47533 47547 47548 47591 47831 47843 47882 47607 47583 47625 47626 47627 47628 47629 47630 47675 47676 47786 47509 47525 47765 47848 47517 47504 47579 47683 47688 47737 47784 47808 47810 47812 47511 47520 47536 47543 47553 47561 47562 47564 47634 47646 47671 47681 47694…
FDA’s list runs to 3,174 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 3,174 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.