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.
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 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
- Affected units
- 3
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.
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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