4 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
FDA Recall
Open, Classified
·Philips North America·Product code LNH·June 30, 2025
SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
FDA Recall
Open, Classified
·Philips North America·Product code LNI·January 3, 2024