Philips Evolution Upgrade 1.5T MRI Stiffness Calculation Error
Philips North America is recalling Philips Evolution Upgrade 1.5T MRI systems with MR Elastography due to potential stiffness value errors that may result in incorrect voxel size settings in the default scan protocol.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device. The hazard involves potential measurement errors in diagnostic imaging that could lead to misinterpretation of patient data, which constitutes a risk of harm to patients, though no actual illnesses or injuries are reported in the source text.
Plain-English summary
Philips North America is recalling the Philips Evolution Upgrade 1.5T with MR Elastography (MRE) medical imaging system. The recall affects 8 units distributed worldwide, including the United States and 37 other countries and territories.
The recalled devices may display stiffness value errors when specific image reconstruction parameters are used in combination with Resoundant's algorithm. This combination can cause the reconstruction voxel size settings in the default MRE scan protocol to display incorrectly as too small.
The affected models are REF 782116 (Serial Numbers 41527, 70949, 84741), REF 782148 (Serial Numbers 84560, 41277, 70769, 70983), and REF 782166 (Serial Number 70042). Healthcare facilities that operate these systems should contact Philips North America for corrective actions and guidance on affected imaging protocols.
The recalled product
- Product
- Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
- Manufacturer
- Philips North America
- Hazard
- measurement-error
- image-reconstruction-error
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 (10)
- 1. Model Number (REF): 782116. UDI: (01)00884838099722(21)41527
- (01)00884838099722(21)70949
- (01)00884838099722(21)84741. Serial Numbers: 41527
- 70949
- 84741. 2. Model Number (REF): 782148. UDI: (01)00884838108714(21)84560
- (01)00884838108714(21)41277
- (01)00884838108714(21)70769
- (01)00884838108714(21)70983. Serial Numbers: 84560
- 41277
- 70769
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