Philips Ingenia 1.5T CX MRI Machine MRE Stiffness Measurement Error
Philips is recalling the Ingenia 1.5T CX MRI machine with MR Elastography because certain image reconstruction parameters may cause stiffness value measurement errors in the default 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. The source text contains no reports of patient harm, illness, or injury. The hazard is a measurement error in a diagnostic imaging parameter—a software or configuration issue rather than a hardware failure or safety defect that would immediately endanger patients.
Plain-English summary
Philips North America is recalling the Ingenia 1.5T CX with MR Elastography (Model 781262, Serial Number 77144) due to a potential error in stiffness value calculations. When specific image reconstruction parameters are used in combination with Resoundant's algorithm, the reconstruction voxel size settings in the default MRE scan protocol may display incorrectly as too small.
This error could affect the accuracy of MR Elastography measurements used to assess tissue stiffness in clinical diagnostics. The affected device has been distributed worldwide, including throughout the United States and 45 other countries.
Physicians and medical facilities using this device should review Philips' communications regarding the identified parameter combinations and updated protocols. Users should verify their scan reconstruction settings and contact Philips for technical guidance if needed.
The recalled product
- Product
- Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
- Manufacturer
- Philips North America
- Hazard
- measurement-error
- mis-calibration
Distribution
Distributed nationwide across the United States.
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