Philips SmartPath to dStream MR Elastography System Reconstruction Error
Philips is recalling certain SmartPath to dStream 1.5T MR Elastography systems due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause incorrect voxel size settings in the default MRE 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 illnesses or injuries. The hazard is a potential measurement error in image reconstruction parameters that may affect scan protocol settings, representing a low-risk condition without evidence of actual patient harm.
Plain-English summary
Philips North America is recalling 6 units of the SmartPath to dStream 1.5T with MR Elastography (MRE) systems, models 781260 and 782112. The systems are affected by a potential error in stiffness value calculation when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. This condition can result in the reconstruction voxel size settings in the default MRE scan protocol displaying as too small.
The recall affects units distributed worldwide, including across 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 units can be identified by their Model Numbers (REF 781260 or 782112) and specific serial numbers. Model 781260 units have serial numbers 21554, 13018, or 12033. Model 782112 units have serial numbers 30143, 22051, or 32156. Healthcare providers and facilities using these systems should contact Philips North America for guidance on remediation or further instructions.
The recalled product
- Product
- Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
- Manufacturer
- Philips North America
- Affected units
- 6
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 (9)
- 1. Model Number (REF): 781260. UDI: (01)00884838095076(21)21554
- (01)00884838095076(21)13018
- (01)00884838095076(21)12033. Serial Numbers: 21554
- 13018
- 12033. 2. Model Number (REF): 782112. UDI: (01)00884838098886(21)30143
- (01)00884838098886(21)22051
- (01)00884838098886(21)32156. Serial Numbers: 30143
- 22051
- 32156.
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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