6 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
FDA Recall
Open, Classified
·Philips North America·Product code LNH·June 30, 2025
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 13, 2025
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·April 23, 2021
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·April 23, 2021