Stop using now Medical device recall · FDA · Published November 22, 2022

Philips SmartPath to Ingenia Elition X MRI System Recall: Heat Risk from Gradient Coil

Philips recalls specific MRI systems due to gradient coil heat risk. Affected models may produce smoke/fire. No remedy provided in official notice.

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

🇺🇸 FDA recall #Z-0461-2023Medical device Philips ›

Stop using this now

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

Take action

Contact the company

Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289

✎ GovInfoNow plain-language explainer

Philips is recalling certain MRI systems that could overheat and cause smoke or fire. This recall affects specific model numbers sold in the US. The hazard is serious but no fix is offered. Read more at govinfonow.com/recall/59293-philips-smartpath-to-ingenia-elition-x-mri-system-recall-heat.

Source Summary by GovInfoNow · govinfonow.com/recall/59293-philips-smartpath-to-ingenia-elition-x-mri-system-recall-heat · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0461-2023

Cite this page

“Philips SmartPath to Ingenia Elition X MRI System Recall: Heat Risk from Gradient Coil.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59293-philips-smartpath-to-ingenia-elition-x-mri-system-recall-heat. Based on FDA recall #Z-0461-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0461-2023%22&limit=1).

Philips North America Llc recalled Philips SmartPath to Ingenia Elition X MR Systems due to a gradient coil hazard that may produce smoke and fire, the FDA said on Nov. 22, 2022. The voluntary Class II recall affects 566 units distributed nationwide.

How to tell if you have it

Brand: Philips
Product: SmartPath to Ingenia Elition X MR System
Model Numbers: 782118, 782132, 782144

The hazard

The gradient coil may act as a heat source with a potential to produce smoke and/or fire. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Philips North America Llc has 129 other recalls on record since 2017-07-12. Other recent recalls of similar products include I.T.S. DUL/UOL Systems Risk MRI Heating (2026-01-23), I.T.S. Hand Locking Plates System: MRI Safety Risk (2026-01-23), and I.T.S. Distal Humeral Plates Risk MRI Heating (2026-01-23).

How to tell if you have this one

Check for model numbers 782118, 782132, or 782144 on the MRI system. Serial numbers are included in the recall letter but no devices were distributed in the US for these models.

Brand
Philips
Category
Medical device

FDA recall event · 5 products

All 5 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.

Recall number	Product, codes & lots	Quantity
Z-0459-2023	Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137; Model 781357: UDI-DI: 00884838088108; Serial Numbers: 46002 46014 46025 46065 46077 46088 46097 46109 46071; Model 782106: UDI-DI: 00884838098329; Serial Numbers: 46224 46225 46265 46269 46311; Model Number 782137: UDI-DI: 00884838108615; Serial Numbers: Included in Letter but No Devices Distributed in the US.	566 total
Z-0460-2023	Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136; Model 781358: UDI-DI: 00884838088115; Serial Numbers: 45002 45051 45075 45108 45133 45164 45243 45269 45337 45356 45010 45053 45086 45112 45147 45178 45245 45296 45338 45357 45011 45054 45087 45113 45150 45179 45247 45321 45343 45364 45024 45060 45089 45124 45152 45194 45252 45322 45353 45395 45027 45068 45099 45132 45161 45238 45263 45335 45355 45414 45026 45055 45082 45100 45235 45237 45264 45315 45398 45423 45032 45078 45092 45146 45236 45261 45277 45316 45399 45429 45035; Model Number 782107: UDI-DI: 00884838098336; Serial Numbers: 45563 45570; Model Number 782119: UDI-DI: 00884838104129; Serial Numbers: Included in Letter but No Devices Distributed in US Model Number 782136: UDI-DI: 00884838108608; Serial Numbers: Included in Letter but No Devices Distributed in US	566 total
Z-0461-2023	Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144; Model 782118: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782132: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782144: Serial Numbers: Included in Letter but No Devices Distributed in the US.	566 total
Z-0462-2023	Philips MR 7700 System, Model Number 782120; Model 782120: UDI-DI: 00884838104112; Serial Numbers: 65005 65006 65007 65008	566 total
Z-0463-2023	Philips Upgrade to MR 7700 System, Model Number 782130; Model 782120: UDI-DI: 00884838104402; Serial Numbers: 45298 45301	N/A

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediate discontinuation of use is required as the gradient coil poses a fire risk during normal operation.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 22 days after the firm started it.

Nov 22, 2022Firm started the recall
Dec 8, 2022FDA classified it Class II
Dec 14, 2022Published in FDA’s Enforcement Report

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

What should I do if I have this model?

Stop using it immediately and contact Philips for further instructions.

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Link to this recall

<a href="https://govinfonow.com/recall/59293-philips-smartpath-to-ingenia-elition-x-mri-system-recall-heat">Philips SmartPath to Ingenia Elition X MRI System Recall: Heat Risk from Gradient Coil (GovInfoNow)</a>

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-0461-2023 (November 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0461-2023 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.