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FDA recall, , Moderate risk

Philips Ingenia, MR 7700 and Evolution MR Systems

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Summary by Recall Canary from the FDA notice

What happened

Philips North America of Cambridge, Massachusetts, recalled several MR systems with SW version R11.1 and R12.1, including the Ingenia 3.0T, Ingenia Elition S, MR 7700, SmartPath to dStream for 3.0T, Ingenia Elition X, Ingenia Ambition X, Evolution Upgrade 1.5T, Ingenia 1.5T, and other models, due to the potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

The recall began December 3, 2025, and was added to the FDA's Enforcement Report on January 29, 2026, with distribution across the U.S. and internationally.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

13 products

Affected if its UDI-DI is listed.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838055339
    • 00884838009813

  2. Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838088108
    • 00884838098329
    • 00884838108615

  3. MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838104112
    • 00884838112858

  4. SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838108684

  5. Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838088115
    • 00884838098336
    • 00884838108608

  6. Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838090040
    • 00884838098350
    • 00884838108622

  7. Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838108714
    • 00884838099722

  8. Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838055322
    • 00884838009820

  9. Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838068452

  10. Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838104402

  11. Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838108660

  12. Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838098343

  13. SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

    UDI-DI
    • 00884838095083

Recall details

Company began the recall
Sold in

Worldwide - US Nationwide distribution in the states of Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.

Company
Philips North AmericaCambridge, Massachusetts
Hazard
Device defect
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
98111
Recall numbers
Z-1204-2026 to Z-1216-2026

All recalls from Philips North America

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

More from Philips North America

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Summary by Recall Canary, written with AI · summary updated Oct 23, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)