8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 13, 2025
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
FDA Recall
Open, Classified
·Philips North America·Product code LNH·June 30, 2025
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Ingenia Elition X- 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) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·November 22, 2022
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
FDA Recall
Open, Classified
·Philips North America·Product code LNH·June 12, 2023
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
FDA Recall
Open, Classified
·Philips North America·Product code LNH·June 12, 2023
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026