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FDA recall, , Moderate risk

Philips MRI Systems with MR Elastography

Philips Achieva 1.5T with MR Elastography may display stiffness values that are too small.

Summary by Recall Canary from the FDA notice

What happened

Philips North America, of Cambridge, Massachusetts, recalled several Philips systems with MR Elastography because a specific range of image reconstruction parameters used with Resoundant's algorithm may cause stiffness value errors, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

The recall began April 14, 2026, and was added to the FDA's Enforcement Report on April 27, 2026. The products were distributed nationwide and in many countries worldwide.

More software 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?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

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

  1. Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

    UDI-DI
    • 00884838108684

  2. Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.

    UDI-DI
    • 00884838099746
    • 00884838108677
    • 00884838115743

  3. Product details

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    UDI-DI
    • 00884838055339
    • 00884838009813
    • 00884838098299

  4. Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.

    UDI-DI
    • 00884838090057
    • 00884838098343
    • 00884838108639

  5. Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.

    UDI-DI
    • 00884838108660
    • 00884838115736

  6. Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    UDI-DI
    • 00884838068452
    • 00884838098312

  7. Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.

    UDI-DI
    • 00884838068445

  8. Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.

    UDI-DI
    • 00884838004108

  9. Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    UDI-DI
    • 00884838088115
    • 00884838098336
    • 00884838108608

  10. Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.

  11. Product details

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    UDI-DI
    • 00884838099715
    • 00884838055322
    • 00884838009820
    • 00884838099043

  12. Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.

    UDI-DI
    • 00884838104112
    • 00884838112858

  13. Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.

    UDI-DI
    • 00884838004139

  14. Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.

    UDI-DI
    • 00884838088108
    • 00884838098329
    • 00884838108615

  15. Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.

    UDI-DI
    • 00884838099722
    • 00884838108714
    • 00884838115774

  16. Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.

    UDI-DI
    • 00884838090040
    • 00884838098350
    • 00884838108622
    • 00884838115712

  17. Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.

    UDI-DI
    • 00884838095076
    • 00884838098886

  18. Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

    UDI-DI
    • 00884838104402

  19. Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.

    UDI-DI
    • 00884838095083
    • 00884838098909

Recall details

Company began the recall
Sold in

Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.

Company
Philips North AmericaCambridge, Massachusetts
Hazard
Software 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
98779
Recall numbers
Z-1951-2026 to Z-1969-2026

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. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Same product, other recalls

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)