7 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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 (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device

FDA Recall
Terminated ·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·March 25, 2019

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