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Lower risk Medical device recall · FDA · Published June 12, 2023

Philips Ingenia Elition X MRI System Recall: SmokeDetector Interlock Cable Installation

Philips recalls Ingenia Elition X MRI systems with specific product numbers due to potential improper installation of the SmokeDetector Interlock cable, which does not affect system functionality but may require service diagnostics.

🇺🇸 FDA recall #Z-2398-2023Medical devicePhilips ›
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Recalling firmPhilips North America222 Jacobs St · Cambridge, MA 02141-2296
✎ GovInfoNow plain-language explainer

Philips is recalling certain Ingenia Elition X MRI systems because a connecting cable for the SmokeDetector Interlock might not have been installed correctly during service. This issue does not affect the system's normal operation but could impact service diagnostics. Read more at govinfonow.com/recall/57858-philips-ingenia-elition-x-mri-system-recall-smokedetector-interlock-cable.

Source Summary by GovInfoNow · govinfonow.com/recall/57858-philips-ingenia-elition-x-mri-system-recall-smokedetector-interlock-cable · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2398-2023

Cite this page

“Philips Ingenia Elition X MRI System Recall: SmokeDetector Interlock Cable Installation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57858-philips-ingenia-elition-x-mri-system-recall-smokedetector-interlock-cable. Based on FDA recall #Z-2398-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2398-2023%22&limit=1).

Philips North America recalled Ingenia Elition X Magnetic Resonance systems on June 12, 2023, according to the FDA. The recall addresses potential improper installation of a connecting cable between the SmokeDetector Interlock and host PC during installation.

How to tell if you have it

  • Brand: Philips
  • Product: Ingenia Elition X Magnetic Resonance (MR) system
  • Product Numbers: 781358, 782107, and 782118
  • Total units affected: 601

The hazard

The connecting cable between the SmokeDetector Interlock and the host PC may not have been properly installed during installation. This connection is used for service diagnostics and does not impact the functionality of the system or the SmokeDetector Interlock system.

Context

GovInfoNow's records show Philips North America has 30 other recalls on record since December 24, 2020. Other recent recalls of similar products include Ingenia 1.5T recalls (August 28, 2026), PIC iX Essentials Software freezes (July 31, 2026), and MR 7700 MRE device upgrades (April 14, 2026). Additional recent Philips recalls include Integris-Allura System oil leak risks (April 28, 2026), Azurion System cable hose carrier issues (March 31, 2026), and Incisive CT unstable sensors (December 3, 2025).

How to tell if you have this one

Check for product numbers 781358, 782107, or 782118 on the MRI system. The system may have specific serial numbers listed in the recall notice.

  • Brand
    Philips
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide. Global Distribution.
Recall numberProduct, codes & lotsQuantity
Z-2398-2023Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X); Product Number 781358: UDI-DI: 00884838088115; Serial Numbers: 45481 45476 45473 45470 45469 45467 45464 45463 4546145459 45456 45451 45450 45448 45447 45446 45444 45443 45442 45441 45439 45438 45437 45435 45434 45432 45429 4542845426 45423 45421 45419 45417 45416 45414 45412 45411 45410 45409 45408 45407 45406 45399 45398 45397 45396 4539545394 45393 45392 45391 45390 45382 45381 45379 45378 45377 45376 45374 45372 45371 45370 45369 45368 45367 4536445363 45362 45360 45359 45357 45356 45355 45354 45353 45352 45350 45349 45348 45345 45344 45343 45342 45340 4533945338 45337 45335 45333 45332 45330 45328 45323 45322 45321 45320 45319 45317 45316 45315 45314 45313 45312 4531145310 45309 45308 45307 45306 45305 45304 45303 45302 45300 45296 45295 45294 45293 45292 45290 45289 45284 4528245281 45280 45279 45278 45277 45276 45274 45272 45269 45268 45267 45265 45264 45263 45262 45261 45260 45259 4525745253 45252 45250 45249 45248 45247 45246 45245 45244 45243 45242 45241 45238 45237 45236 45235 45231 45229 4522845227 45224 45222 45220 45219 45218 45217 45216 45215 45212 45211 45210 45207 45205 45204 45203 45197 45195 4519445193 45192 45191 45190 45189 45188 45187 45186 45185 45184 45183 45181 45180 45179 45178 45177 45176 45174 4517145170 45169 45168 45165 45164 45163 45162 45161 45160 45159 45158 45157 45156 45155 45154 45153 45152 45151 4515045149 45148 45147 45146 45145 45144 45142 45141 45140 45139 45138 45137 45136 45134 45133 45132 45131 45129 4512845127 45124 45123 45122 45121 45120 45119 45118 45116 45115 45114 45113 45112 45111 45109 45108 45107 45106 45105 4510245100 45099 45098 45097 45096 45095 45094 45093 45092 45091 45090 45089 45088 45087 45086 45085 45084 45082 4508145080 45079 45078 45077 45076 45075 45072 45071 45070 45068 45067 45066 45065 45064 45062 45061 45060 45058 4505645055 45054 45053 45052 45051 45050 45049 45048 45047 45046 45045 45044 45043 45042 45041 45040 45039 45037 4503645035 45034 45033 45032 45031 45030 45029 45028 45027 45026 45025 45024 45023 45011 45010 45009 45008 45001 4500045002 45471 45073 45474 45480; Product Number 782107: UDI-DI: 00884838098336; Serial Numbers: 62147 62120 62091 6208362082 62081 62080 62073 62071 62070 62056 62041 62040 62039 62038 62033 62031 62030 62027 62023 62021 62017 6201662012 62011 45600 45599 45596 45595 45594 45589 45583 45580 45578 45577 45574 45573 45572 45570 45568 45567 4556645565 45564 45563 45562 45561 45560 45559 45556 45555 45554 45552 45550 45547 45546 45545 45544 45543 45542 4554045538 45536 45534 45533 45532 45531 45530 45528 45525 45524 45523 45521 45520 45519 45518 45517 45516 45514 4551145510 45509 45508 45507 45506 45504 45503 45501 45500 62019 62024 62037 62042 62046 62088 62044; Product Number 782118; UDI-DI: 00884838099746; Serial Numbers: 85661 71060 42054 42085 42113 42306 42329 71019 71025601 Total
Z-2399-2023Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106; Product Number: 781357: UDI-DI: 00884838088108 Serial Numbers: 46119 46111 46109 46107 46104 46101 46097 46095 4609446093 46092 46089 46088 46086 46085 46084 46083 46082 46081 46078 46077 46076 46075 46071 46069 46068 46067 4606646065 46061 46060 46059 46058 46057 46055 46054 46053 46052 46050 46049 46048 46046 46045 46044 46042 46041 4603946037 46036 46034 46033 46032 46031 46030 46029 46027 46026 46025 46024 46023 46021 46020 46019 46018 46017 4601646015 46014 46013 46012 46011 46008 46007 46005 46004 46003 46002 46001 46121; Product Number 782106: UDI-DI:00884838098329 Serial Numbers: 61017 61010 46324 46315 46311 46310 46304 46289 46286 46285 46282 46270 46269 4626846265 46258 46252 46249 46247 46243 46241 46240 46239 46237 46235 46234 46233 46231 46228 46226 46225 46224 4622246220 46219 46218 46217 46215 46214 46213 46212 46211 46209 46208 46207 46206 46205 46204 46203 46202 46201 4620046242 46245 46263 46305 46264 46281601 Total
Z-2400-2023MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700); Product Number: 782120: UDI-DI: 00884838104112; Serial Numbers: 65041 65031 65030 65025 65023 65019 65013 65009 6500865007 65006 65005 65004 65003 65002 65000 65020; Product Number 782130: UDI-DI: 00884838104402; Serial Numbers: 4530145298 45007 45297601 total
Based on the official FDA remedy

What to do — step by step

  1. Check Product Numbers

    Identify if your MRI system has product numbers 781358, 782107, or 782118.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide. Global Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jun 12, 202312. FDA classified it Class II: Aug 10, 202323. Published in FDA’s Enforcement Report: Aug 16, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2398-2023 (June 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2398-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA