Philips SmartPath to dStream MR Elastography Software Parameter Error
Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.
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 illnesses or injuries. The hazard is a measurement/display error in scan parameters that could affect image analysis but does not directly pose acute patient harm if recognized and corrected by trained operators. The source text does not indicate any known adverse events or hospitalizations.
Plain-English summary
Philips North America is recalling 14 units of SmartPath to dStream for XR and 3.0T with MR Elastography (Model Numbers 781270 and 782113). The recall addresses a potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
The affected devices are distributed worldwide, including the United States and numerous countries across Europe, Asia, South America, Africa, and the Middle East. Specific serial numbers and UDI codes have been identified for both model numbers.
Users of affected units should contact Philips North America for further guidance regarding this recall. This is a Class II recall classified by the FDA.
The recalled product
- Product
- Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
- Manufacturer
- Philips North America
- Affected units
- 14
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): 781270. UDI: (01)00884838095083(21)38109
- (01)00884838095083(21)17386
- (01)00884838095083(21)38356
- (01)00884838095083(21)34211
- (01)00884838095083(21)38113
- (01)00884838095083(21)17356
- (01)00884838095083(21)38111
- (01)00884838095083(21)74011
- (01)00884838095083(21)24058
- (01)00884838095083(21)24066
- (01)00884838095083(21)34223. Serial Numbers: 38109
- 17386
- 38356
- 34211
- 38113
- 17356
- 38111
- 74011
- 24058
- 24066
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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