Philips SmartPath dStream 3.0T MRI Scanner Software Parameter Error Recall
Philips is recalling one unit of the SmartPath to dStream 3.0T MRI scanner with MR Elastography due to potential stiffness value calculation errors when specific image reconstruction parameters are used.
What this means for you
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 involving a medical device software parameter error. No reported illnesses, injuries, or hospitalizations are stated in the source text. The hazard is a potential calculation error in diagnostic imaging, which presents a risk of incorrect diagnostic results rather than imminent harm to patient safety.
Plain-English summary
Philips North America is recalling the SmartPath to dStream 3.0T MRI scanner with MR Elastography (Model Number REF 782145, Serial Number 17385) due to a software error affecting stiffness value calculations.
The defect occurs when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. This combination causes the reconstruction voxel size settings in the default MRE scan protocol to display incorrectly as too small.
This scanner was distributed worldwide, including throughout the US and to 46 countries. Affected healthcare facilities using this device with the implicated parameter settings may obtain incorrect stiffness values during magnetic resonance elastography scans.
Anyone with this device should contact Philips North America for guidance on software corrections or other remedial steps.
The recalled product
- Product
- Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
- Manufacturer
- Philips North America
- Hazard
- software-error
- mis-calibration
Distribution
Distributed nationwide across the United States.
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