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Use caution Medical device recall · FDA · Published July 30, 2021

Philips Ingenia Elition MRI Systems Recall: Risk of Helium Gas Release

Philips recalls Ingenia Elition X-MRI systems with faulty pressure relief valve that may release helium gas, causing injury. Affected units have specific model and serial numbers. Consumers should contact Philips for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2344-2021Medical devicePhilips ›
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Contact the company

Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289
✎ GovInfoNow plain-language explainer

Philips is recalling Ingenia Elition X-MRI systems that have a pressure relief valve set to 42 psi instead of the correct 3.75 psi. This could cause helium gas to be released, potentially leading to injury. Affected units have specific model and serial numbers. Read more at govinfonow.com/recall/62112-philips-ingenia-elition-mri-systems-recall-risk-of-helium-gas.

Source Summary by GovInfoNow · govinfonow.com/recall/62112-philips-ingenia-elition-mri-systems-recall-risk-of-helium-gas · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2344-2021

Cite this page

“Philips Ingenia Elition MRI Systems Recall: Risk of Helium Gas Release.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62112-philips-ingenia-elition-mri-systems-recall-risk-of-helium-gas. Based on FDA recall #Z-2344-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2344-2021%22&limit=1).

The FDA announced on July 30, 2021, that Philips North America LLC recalled Ingenia Elition X-Magnetic Resonance Medical Electrical Systems due to a pressure relief valve hazard. The incorrect valve may release helium gas and cause injury.

How to tell if you have it

  • Brand: Philips
  • Product: Ingenia Elition X-Magnetic Resonance Medical Electrical Systems
  • Model Number: 781358
  • UPC: 00884838088115
  • Serial Numbers and UDI: US: 45245 (01)00884838088115(21)45245; 45247 (01)00884838088115(21)45247; 45261 (01)00884838088115(21)45261; 45263 (01)00884838088115(21)45263; 45264 (01)00884838088115(21)45264; 45269 (01)00884838088115(21)45269; OUS: 45215 (01)00884838088115; 45284 (01)00884838088115; 45253 (01)00884838088115; 45313 (01)00884838088115; 45265 (01)00884838088115; 45297 (01)00884838088115; 45218 (01)00884838088115; 45272 (01)00884838088115; 45281 (01)00884838088115; 45231 (01)00884838088115; 45278 (01)00884838088115; 45279 (01)00884838088115; 45245 (01)00884838088115; 45247 (01)00884838088115

The hazard

According to the FDA, a pressure relief valve rated for 42 psi was installed in the magnet assembly instead of the required 3.75 psi valve. This error may result in the release of helium gas and cause injury.

Context

GovInfoNow's records show Philips North America LLC has 129 other recalls on record since July 12, 2017. Recent Philips recalls include an Evolution upgrade software issue (August 21, 2026), a Spectral CT 7500 Scanner radiation exposure risk (August 18, 2026), and an Ingenuity CT Scanner unintended radiation risk (August 7, 2026). Other recent recalls of similar products include Canon Vantage Titan 3T MRI Systems Recall: Ice Risk in Venting System (December 19, 2025) and Canon Medical Vantage Galan 3T MRI Recall: Ice Risk in Superconducting Magnet (December 19, 2025).

How to tell if you have this one

Check for model number 781358 on the system. Serial numbers and UDI codes include specific patterns like US: 45245 (01)00884838088115(21)45245.

  • Brand
    Philips
  • Product
    Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system
  • Category
    Medical device
FDA recall event · 7 products

All 7 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
    Terminated
  • Distribution
    Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-2341-2021Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781315; S/N and UDI: US: 61044 (01)00884838099715(21)61044; 61047 (01)00884838099715(21)61047. OUS: 61028 (01)00884838099715 61008 (01)00884838099715 61025 (01)00884838099715 61026 (01)00884838099715 61034 (01)00884838099715 61035 (01)00884838099715 61042 (01)00884838099715 61046 (01)00884838099715 61040 (01)00884838099715 61041 (01)00884838099715 61018 (01)00884838099715 61017 (01)00884838099715 61032 (01)00884838099715 61043 (01)00884838099715 61033 (01)00884838099715 61064 (01)008848380997152 units US; 16 units OUS
Z-2342-2021Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781341; S/N and UDI: 84344 (01)00884838055322(21)84344; 87019 (01)00884838055322(21)87019; 87231 (01)00884838055322(21)87231. OUS: 87171 (01)00884838055322 84943 (01)00884838055322 87142 (01)00884838055322 87249 (01)00884838055322 87252 (01)00884838055322 87195 (01)00884838055322 87129 (01)00884838055322 87136 (01)00884838055322 87175 (01)00884838055322 87196 (01)00884838055322 87197 (01)00884838055322 87235 (01)00884838055322 87187 (01)00884838055322 87212 (01)00884838055322 84572 (01)00884838055322 87116 (01)00884838055322 87152 (01)00884838055322 87161 (01)00884838055322 87237 (01)00884838055322 87244 (01)00884838055322 87090 (01)00884838055322 87093 (01)00884838055322 87259 (01)00884838055322 87209 (01)008848380553223 units US; 24 units OUS
Z-2343-2021Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781342; S/N and UDI: 85275 (01)00884838055339(21)85275; 85278 (01)00884838055339(21)85278; 85394 (01)00884838055339(21)85394. OUS: 85393 (01)00884838055339 85332 (01)00884838055339 85334 (01)00884838055339 85336 (01)00884838055339 85349 (01)00884838055339 85350 (01)00884838055339 85355 (01)00884838055339 85370 (01)00884838055339 85371 (01)00884838055339 85382 (01)00884838055339 85384 (01)00884838055339 85385 (01)00884838055339 85398 (01)00884838055339 85348 (01)00884838055339 85149 (01)00884838055339 85367 (01)00884838055339 85388 (01)008848380553393 units US; 17 units OUS
Z-2344-2021Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781358; S/N and UDI: US: 45245 (01)00884838088115(21)45245; 45247 (01)00884838088115(21)45247; 45261 (01)00884838088115(21)45261; 45263 (01)00884838088115(21)45263; 45264 (01)00884838088115(21)45264; 45269 (01)00884838088115(21)45269; OUS: 45215 (01)00884838088115; 45284 (01)00884838088115; 45253 (01)00884838088115; 45313 (01)00884838088115; 45265 (01)00884838088115; 45297 (01)00884838088115; 45218 (01)00884838088115; 45272 (01)00884838088115; 45281 (01)00884838088115; 45231 (01)00884838088115; 45278 (01)00884838088115; 45279 (01)00884838088115; 45245 (01)00884838088115; 45247 (01)00884838088115;6 units; 12 OUS
Z-2345-2021Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 78127 (OUS); S/N and UDI: 78189 (01)00884838068452; 78272 (01)00884838068452; 78294 (01)00884838068452; 78295 (01)00884838068452; 78332 (01)00884838068452; 78335 (01)00884838068452; 78340 (01)00884838068452; 78345 (01)00884838068452; 78249 (01)00884838068452; 78324 (01)00884838068452; 78326 (01)0088483806845211 units
Z-2346-2021Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781277 (OUS); S/N and UDI: N/A1 unit
Z-2347-2021Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781357 (OUS); S/N and UDI: 46083 (01)00884838088108; 46084 (01)00884838088108; 46086 (01)00884838088108; 46054 (01)00884838088108; 46058 (01)00884838088108; 46082 (01)00884838088108; 46061 (01)00884838088108;7 units
Based on the official FDA remedy

What to do — step by step

  1. Contact Philips

    Reach out to Philips for specific details about your unit and instructions on how to proceed.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 12 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas, Virginia.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Jul 30, 202112. FDA classified it Class II: Aug 25, 202123. Published in FDA’s Enforcement Report: Sep 1, 202134. FDA terminated the recall: Jul 25, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How can I tell if my unit is affected?

Check for model number 781358 and serial numbers starting with US: 45245, 45247, 45261, 45263, 45264, 45269, or OUS: 45215, 45284, 45253, 45313, 45265, 45297, 45218, 45272, 45281, 45231, 45278, 45279, 45245, 45247.

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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-2344-2021 (July 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2344-2021 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