Philips Ingenia Elition X MRI Scanner Recall for Image Reconstruction Error
Philips is recalling Ingenia Elition X MRI scanners with MR Elastography due to potential errors in stiffness value measurements when specific image reconstruction parameters are used, which may cause incorrect voxel size display 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 with no reported hospitalizations or injuries. The source explicitly describes a measurement display error with no statement of illness or harm; therefore, per the rubric, the score is 2 (Moderate).
Plain-English summary
Philips North America is recalling the Ingenia Elition X with MR Elastography (MRE) medical imaging system due to a potential issue with stiffness value errors. The error occurs when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, causing the reconstruction voxel size settings in the default MRE scan protocol to display too small.
The affected devices include Model Numbers REF 781358, REF 782107, and REF 782136, totaling approximately 103 units worldwide. These systems have been distributed in the United States and numerous countries including Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Federation, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and the United Kingdom.
Patients and healthcare providers with these devices should contact Philips North America for further guidance. The FDA has classified this as a Class II recall. For more information, refer to FDA recall number Z-1963-2026.
The recalled product
- Product
- Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
- Manufacturer
- Philips North America
- Affected units
- 103
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): 781358. UDI: (01)00884838088115(21)45121
- (01)00884838088115(21)45148
- (01)00884838088115(21)45160
- (01)00884838088115(21)45438
- (01)00884838088115(21)45034
- (01)00884838088115(21)45049
- (01)00884838088115(21)45066
- (01)00884838088115(21)45090
- (01)00884838088115(21)45141
- (01)00884838088115(21)45149
- (01)00884838088115(21)45170
- (01)00884838088115(21)45250
- (01)00884838088115(21)45290
- (01)00884838088115(21)45085
- (01)00884838088115(21)45312
- (01)00884838088115(21)45376
- (01)00884838088115(21)45122
- (01)00884838088115(21)45169
- (01)00884838088115(21)45191
- (01)00884838088115(21)45192
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.
See all 19 products in this recall →Related recalls
Same manufacturer · Philips North America
See all →- ModeratePhilips MR 5300 Recalled for Incorrect Diffusion Tensor Imaging Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
Same hazard · measurement error
See all →- ModeratePhilips MR 7700 MRE Upgrade MRI Equipment Stiffness Value Error Risk
FDA (Devices) · 2026-05-06
- HighPhilips Evolution Upgrade 1.5T MRI Stiffness Calculation Error
FDA (Devices) · 2026-05-06
- ModeratePhilips SmartPath to Ingenia Elition X MR Elastography Stiffness Value Errors
FDA (Devices) · 2026-05-06
- ModeratePhilips Ingenia Ambition X MRI Systems Stiffness Value Error Recall
FDA (Devices) · 2026-05-06
- ModeratePhilips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall
FDA (Devices) · 2026-05-06
Similar recalls
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- HighIngenia Elition X systems recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04
- ModeratePhilips Ingenia Elition X MRI System Alignment Error Recall
FDA (Devices) · 2025-05-28
- HighIngenia Ambition X systems recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04
- HighIngenia Elition S systems recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04
- ModeratePhilips Ingenia Elition S MRI System Alignment Error Recall
FDA (Devices) · 2025-05-28