Reported Feb 4, 2026 · Ongoing

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

Philips North America

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America · 222 Jacobs St · Cambridge, MA · 02141-2296

Is this the product you have?

  • Ingenia Elition X
  • Product Code (REF)(1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1
Lot codes and dates
  • MR systems with SW version R11.1 and R12.1. (1)
  • Product Code (REF)781358
  • UDI-DI00884838088115
  • Serial Numbers
    • 45414
    • 45245
    • 45090
    • 45049
    • 45034
    • 45250
    • 45075
    • 45290
    • 45320
    • 45011
    • 45191
    • 45277
    • 45278
    • 45028
    • 45147. (2)
  • Product Code (REF)782107
  • UDI-DI00884838098336
  • Serial Numbers
    • 62031
    • 45533
    • 62051
    • 62182
    • 62024
    • 62047
    • 62048
    • 62052
    • 45519
    • 62181
    • 62081
    • 62153
    • 62088
    • 45589
    • 62073. (3)
  • Product Code (REF)782136
  • UDI-DI00884838108608
  • Serial Numbers28503
Amount recalled
31 units

This recall covers 13 products

The agency filed one notice per product. You are reading one of them; the other 12 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.