4 results
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21ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 13, 2025
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
FDA Recall
Open, Classified
·Philips North America·Product code LNH·June 30, 2025
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026