Philips Achieva 3.0T MR Elastography system stiffness value error recall
Philips is recalling the Achieva 3.0T with MR Elastography system due to potential stiffness value errors in image reconstruction when specific 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. The source text does not report any illnesses, injuries, or deaths, and the hazard is a technical measurement error that is theoretical in nature. No adverse health consequences have been reported.
Plain-English summary
Philips North America is recalling the Philips Achieva 3.0T with MR Elastography (MRE) system, Model Number 781278, due to a potential for stiffness value errors in image reconstruction. The error occurs when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to incorrect reconstruction voxel size settings displayed in the default MRE scan protocol.
The device is distributed worldwide, including throughout the United States and internationally. One unit with Serial Number 38103 has been identified in this recall.
Facilities using this device should contact Philips North America for instructions on addressing this issue. The stiffness value errors and voxel size display inaccuracies may affect the reliability of MR elastography measurements.
The recalled product
- Product
- Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
- 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.
See all 19 products in this recall →Related recalls
Same manufacturer · Philips North America
See all →- ModeratePhilips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 5300 Recalled for Incorrect Diffusion Tensor Imaging Data
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI 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
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
- HighIngenia 3.0T CX systems recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04
- HighIngenia 3.0T systems recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04
- HighEvolution Upgrade 3.0T systems recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04
- ModeratePhilips Achieva 3.0T MRI Software Recall for Memory Limit Issues
FDA (Devices) · 2026-09-30
- HighIngenia 1.5T systems recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04
- HighIngenia Elition X systems recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04