Philips SmartPath to Ingenia Elition X MR Elastography Stiffness Value Errors
Philips is recalling three models of SmartPath to Ingenia Elition X with MR Elastography devices due to potential stiffness value errors when specific image reconstruction parameters are combined with Resoundant's algorithm.
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 a potential software or parameter error that could affect diagnostic accuracy. No reported illnesses, injuries, or adverse events are stated in the source. The hazard is a measurement or display error rather than an immediate safety threat, making this a Moderate severity case.
Plain-English summary
Philips North America is recalling three models of the SmartPath to Ingenia Elition X with MR Elastography (MRE) device: Model 782118, Model 782144, and Model 782163. The recall addresses a potential for stiffness value errors when specific image reconstruction parameters are used in combination with Resoundant's algorithm, which can result in reconstruction voxel size settings in the default MRE scan protocol displaying incorrectly as too small.
The affected devices have been distributed worldwide, including throughout the United States and in 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.
Affected individuals should contact Philips North America or consult the device's instructions for guidance on this issue. Healthcare providers and facility administrators should review their inventory for the affected model numbers and serial numbers to determine if any units in their facilities are impacted.
The recalled product
- Product
- Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
- Manufacturer
- Philips North America
- Affected units
- 3
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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