Philips North America — Class II: Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF
Philips North America has initiated a Class II recall for the SmartPath to dStream for 3.0T with MR Elastography (MRE) due to potential stiffness value errors. These errors occur when specific image reconstruction parameters combined with Resoundant's algorithm cause reconstruction voxel size settings in the default MRE scan protocol to appear too small.
This recall affects Philips North America, healthcare facilities utilizing the SmartPath to dStream upgrade for 3.0T MRI systems with MRE capabilities, and clinical staff responsible for liver stiffness quantification workflows.
Inaccurate stiffness values in MR Elastography could potentially lead to the misinterpretation of tissue characteristics. This suggests a technical vulnerability in the integration of third-party algorithms with default manufacturer scan protocols, highlighting the need for rigorous verification of reconstruction parameters during software integration and system upgrades.
QA and clinical engineering teams should verify if local MR Elastography protocols utilize the affected default scan settings and monitor for software updates or parameter corrections from the manufacturer. Regulatory teams should ensure this recall is documented within their post-market surveillance files.
Class II. Reason: The 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.. Product: Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.. Firm: Philips North America (Cambridge MA United States). Status: Ongoing.
Open in openFDA / FDA.gov