Philips Evolution 3.0T MR Elastography upgrade stiffness calculation error
Philips Evolution upgrade 3.0T with MR Elastography systems may produce incorrect stiffness values when specific image reconstruction parameters are used, causing voxel size settings to display smaller than intended.
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 medical device recall. No reported injuries or hospitalizations are stated in the source. The hazard is a potential for measurement error in a diagnostic imaging algorithm, which qualifies as a moderate-risk condition requiring correction but not immediately life-threatening.
Plain-English summary
Philips North America is recalling the Philips Evolution upgrade 3.0T with MR Elastography (MRE) systems (Model Numbers REF 782143 and REF 782162). The recall affects 3 units distributed worldwide, including the United States and multiple international locations.
The issue involves a potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. This can cause the reconstruction voxel size settings in the default MRE scan protocol to display as too small, which may result in inaccurate stiffness calculations.
Affected customers should contact Philips North America regarding the specific serial numbers involved (42218, 42225 for Model REF 782143; 71403 for Model REF 782162) and discuss remediation options.
The recalled product
- Product
- Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
- Manufacturer
- Philips North America
- Hazard
- measurement-error
- mis-calibration
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 (2)
- 1. Model Number (REF): 782143. UDI: (01)00884838108660(21)42218
- (01)00884838108660(21)42225. Serial Numbers: 42218
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateSilastic Brand Foley Catheters recalled due to surface stain
FDA (Devices) · 2026-05-27
- HighIntegris-Allura X-ray systems with degraded deaeration hoses recalled
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27