The Recall Desk
ModerateFDA (Devices)·Z-1959-2026·Announced 2026-05-06

Philips Ingenia 3.0T CX MRI System MR Elastography Software Issue

Philips is recalling Ingenia 3.0T CX MRI systems with MR Elastography due to potential stiffness value errors caused by specific image reconstruction parameters and Resoundant algorithm settings, resulting in incorrect voxel size displays in the default MRE scan protocol.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a software/parameter configuration issue that could affect measurement accuracy. No illnesses, injuries, or deaths are reported in the source text, and the hazard is conditional on specific settings being used together; the defect does not automatically cause harm under all operating conditions.

Plain-English summary

Philips North America is recalling 22 units of the Philips Ingenia 3.0T CX with MR Elastography (MRE) due to a potential software issue affecting stiffness value calculations. The problem occurs when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, which can cause the reconstruction voxel size settings in the default MRE scan protocol to display incorrectly—showing values that are too small.

This issue affects two model numbers: REF 781271 and REF 782105, distributed worldwide across the US and over 50 countries including Canada, Australia, Japan, Germany, United Kingdom, and many others. Affected units are identified by specific UDI codes and serial numbers listed in the recall notice.

The FDA has classified this as a Class II recall. Users should contact Philips North America for instructions on addressing this issue, which may include software updates or protocol adjustments to prevent inaccurate elastography measurements.

The recalled product

Product
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.
Manufacturer
Philips North America
Category
Medical Device — MRI System / Diagnostic Imaging
Hazard
  • measurement-error
  • software-configuration

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1. Model Number (REF): 781271. UDI: (01)00884838068452(21)78017
  • (01)00884838068452(21)78013
  • (01)00884838068452(21)78014
  • (01)00884838068452(21)78034
  • (01)00884838068452(21)78058
  • (01)00884838068452(21)78073
  • (01)00884838068452(21)78075
  • (01)00884838068452(21)78092
  • (01)00884838068452(21)78112
  • (01)00884838068452(21)78123
  • (01)00884838068452(21)78201
  • (01)00884838068452(21)78202
  • (01)00884838068452(21)78215
  • (01)00884838068452(21)78217
  • (01)00884838068452(21)78239
  • (01)00884838068452(21)78247
  • (01)00884838068452(21)78260
  • (01)00884838068452(21)78286
  • (01)00884838068452(21)78287
  • (01)00884838068452(21)78026. Serial Numbers: 78017

Distribution

Distributed nationwide across the United States.

Related recalls

Same category