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Orthofix U.S. LLC: Brand Name: FIREBIRD" SI Fusion System Product Name: FIRE...

Labeling contains claims that are not consistently present.

FDANov 3, 2025Nationwide• Orthofix U.S. LLC

Philips North America Llc: SmartPath to Ingenia Elition X - Magnetic Resonance (MR) ...

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

FDAMay 3, 2024Nationwide• Philips North America Llc

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Orthofix U.S. LLC: Brand Name: FIREBIRD" SI Fusion System Product Name: FIRE...

Philips North America Llc: SmartPath to Ingenia Elition X - Magnetic Resonance (MR) ...

Philips North America Llc: MR RT Upgrades- Magnetic Resonance (MR) systems are Medic...

Philips North America Llc: Upgrade dStream - Magnetic Resonance (MR) systems are Med...

Philips North America Llc: SmartPath to dStream for 1.5T- Magnetic Resonance (MR) sy...

Philips North America Llc: Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems ...

Philips North America Llc: Intera 1.5T- Magnetic Resonance (MR) systems are Medical ...

Philips North America Llc: Panorama HFO- Magnetic Resonance (MR) systems are Medical...

Philips North America Llc: Achieva 3.0T TX for PET Model Number (REF): 781479

Philips North America Llc: Achieva 3.0T for PET -Magnetic Resonance (MR) systems are...

Philips North America Llc: Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical...

Philips North America Llc: Achieva 1.5T- Magnetic Resonance (MR) systems are Medical...

Philips North America Llc: AchievaXR -Magnetic Resonance (MR) systems are Medical El...

Philips North America Llc: Achieva 1.5T Conversion- Magnetic Resonance (MR) systems ...

Philips North America Llc: Evolution upgrade 1.5T- Magnetic Resonance (MR) systems ...

Philips North America Llc: Ingenia Ambition X- Magnetic Resonance (MR) systems are M...

Philips North America Llc: Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Me...

Philips North America Llc: Ingenia Elition X- Magnetic Resonance (MR) systems are M...

Philips North America Llc: MR RT - Magnetic Resonance (MR) systems are Medical Elect...

Philips North America Llc: MR 5300- Magnetic Resonance (MR) systems are Medical Ele...