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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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