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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1856-2024 - Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781474
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2
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05/17/2024
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Philips North America Llc
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Z-1857-2024 - MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781483
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2
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05/17/2024
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Philips North America Llc
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Z-1858-2024 - MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781439
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2
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05/17/2024
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Philips North America Llc
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Z-1859-2024 - MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781440
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2
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05/17/2024
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Philips North America Llc
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Z-1860-2024 - SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF):
782146;
782112;
781260
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2
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05/17/2024
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Philips North America Llc
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Z-1861-2024 - SmartPath to dStream for 3.0T
Model Number (REF): 782145
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2
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05/17/2024
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Philips North America Llc
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Z-1862-2024 - SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF):
(1) 782129;
(2) 782113;
(3) ...
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2
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05/17/2024
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Philips North America Llc
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Z-1863-2024 - SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 782118
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2
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05/17/2024
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Philips North America Llc
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Z-1864-2024 - Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781361
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2
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05/17/2024
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Philips North America Llc
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Z-1837-2024 - Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF):
(1) 781283;
(2) 781346
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2
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05/17/2024
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Philips North America Llc
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