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Lower risk Medical device recall · FDA · Published December 3, 2025

Philips SmartPath to dStream 3.0T: Stiffness errors in MR Elastography images

Philips recalls SmartPath to dStream 3.0T MRI systems with software versions R11.1 and R12.1 due to potential stiffness value errors in MR Elastography images. Affected units may show inaccurate stiffness maps when viewed in PACS.

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

🇺🇸 FDA recall #Z-1215-2026Medical devicePhilips ›
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Contact the company

Recalling firmPhilips North America222 Jacobs St · Cambridge, MA 02141-2296
✎ GovInfoNow plain-language explainer

Philips is recalling certain MRI systems that could display incorrect stiffness values in MR Elastography images. This might lead to inaccurate medical assessments if the images are used for diagnosis. Read more at govinfonow.com/recall/50534-philips-smartpath-to-dstream-3-0t-stiffness-errors-in-mr.

Source Summary by GovInfoNow · govinfonow.com/recall/50534-philips-smartpath-to-dstream-3-0t-stiffness-errors-in-mr · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1215-2026

Cite this page

“Philips SmartPath to dStream 3.0T: Stiffness errors in MR Elastography images.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50534-philips-smartpath-to-dstream-3-0t-stiffness-errors-in-mr. Based on FDA recall #Z-1215-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1215-2026%22&limit=1).

Philips North America recalled SmartPath to dStream for 3.0T MR systems on Dec. 3, 2025, due to potential stiffness value errors in exported MRE maps, the FDA said. The voluntary Class II recall affects one unit distributed worldwide.

How to tell if you have it

  • Brand: Philips
  • Product: SmartPath to dStream for 3.0T
  • Product Code (REF): 782145
  • Software Versions: R11.1 and R12.1
  • UDI-DI: 00884838108684
  • Serial Number: 17385

The hazard

The recall addresses the potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps on a viewer Picture Archiving and Communication System (PACS), according to the FDA.

Context

GovInfoNow's records show Philips North America has 30 other recalls on record since Dec. 24, 2020. Other recent recalls include an Aug. 28, 2026 recall of MR 7700 systems for incorrect diffusion data and a July 31, 2026 recall of PIC iX Essentials Software for freezing issues.

How to tell if you have this one

Check if your Philips SmartPath to dStream 3.0T MRI system has software version R11.1 or R12.1. The product code is 782145, and serial numbers start with 17385.

  • Brand
    Philips
  • Category
    Medical device
FDA recall event · 13 products

All 13 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
    Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-1204-2026Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 782148. UDI-DI: 00884838108714. Serial Numbers: 70769, 70983. (2) Product Code (REF): 782116. UDI-DI: 00884838099722. Serial Number: 84741.3 units
Z-1205-2026Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. Product Code (REF): 782143. UDI-DI: 00884838108660. Serial Numbers: 42225.1 unit
Z-1206-2026Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781341; UDI-DI: 00884838055322; Serial Numbers: 70311, 84560, 84403, 84467, 84462, 70042, 84433. (2) Product Code (REF): 781396; UDI-DI: 00884838009820; Serial Numbers: 41356, 41354, 41370.10 units
Z-1207-2026Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781342; UDI-DI: 00884838055339; Serial Numbers: 71607, 85216, 71087, 71619, 71462, 71002, 71885, 71841, 71378, 71269, 85126, 71279, 71088, 71185, 71532, 71344, 71756, 71336, 71459. (2) Product Code (REF): 781377; UDI-DI: 00884838009813; Serial Numbers: 42305, 42299, 42036, 42376, 42321.24 units
Z-1208-2026Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. Product Code (REF): 781271. UDI-DI: 00884838068452. Serial Numbers: 78017, 78112, 78217, 78123, 78260, 78239.6 units
Z-1209-2026Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. Product Code (REF): 782108. UDI-DI: 00884838098343. Serial Numbers: 48669.1 unit
Z-1210-2026Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781356; UDI-DI: 00884838090040; Serial Numbers: 47206, 47038, 47068, 47260, 47294, 47029, 47189. (2) Product Code (REF): 782109; UDI-DI: 00884838098350; Serial Numbers: 47849, 47634, 47534, 47726, 47760, 47706, 47789, 47642, 47681, 47761, 47771, 47767, 47862. (3) Product Code (REF): 782138; UDI-DI: 00884838108622; Serial Numbers: 49057.21 units
Z-1211-2026Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781357; UDI-DI: 00884838088108; Serial Numbers: 46002. (2) Product Code (REF): 782106; UDI-DI: 00884838098329; Serial Numbers: 46243, 46292. (3) Product Code (REF): 782137; UDI-DI: 00884838108615; Serial Numbers: 64034, 64045.5 units
Z-1212-2026Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781358; UDI-DI: 00884838088115; Serial Numbers: 45414, 45245, 45090, 45049, 45034, 45250, 45075, 45290, 45320, 45011, 45191, 45277, 45278, 45028, 45147. (2) Product Code (REF): 782107; UDI-DI: 00884838098336; Serial Numbers: 62031, 45533, 62051, 62182, 62024, 62047, 62048, 62052, 45519, 62181, 62081, 62153, 62088, 45589, 62073. (3) Product Code (REF): 782136; UDI-DI: 00884838108608; Serial Numbers: 28503.31 units
Z-1213-2026MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 782120; UDI-DI: 00884838104112; Serial Numbers: 65019, 65060, 65066, 65065, 65051, 65038, 65005. (2) Product Code (REF): 782153; UDI-DI: 00884838112858; Serial Numbers: 68010, 68017.9 units
Z-1214-2026Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. Product Code (REF): 782130. UDI-DI: 00884838104402. Serial Numbers: 42030, 85644, 42163, 42151, 45236, 85643.6 units
Z-1215-2026SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. Product Code (REF): 782145. UDI-DI: 00884838108684. Serial Numbers: 17385.1 unit
Z-1216-2026SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.; MR systems with SW version R11.1 and R12.1. Product Code (REF): 781270. UDI-DI: 00884838095083. Serial Numbers: 24066, 38113, 17356.3 units
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your MRI system's software version to see if it is R11.1 or R12.1.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 20 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Illinois, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington.

Recall timeline

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

1. Firm started the recall: Dec 3, 202512. FDA classified it Class II: Jan 29, 202623. Published in FDA’s Enforcement Report: Feb 4, 2026320252026
  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-1215-2026 (December 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1215-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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