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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-1846-2024 - Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF):
(1) 781262
(2) 781261
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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-1847-2024 - Ingenia 1.5T S
Model Number (REF):
781347
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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-1848-2024 - Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF):
(1) 782103
(2) 781377
(3) 781342
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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-1849-2024 - Ingenia 3.0T CX
Model Number (REF):
(1) 782105
(2) 781271
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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-1850-2024 - Ingenia Ambition S
Model Number (REF):
(1) 782139;
(2) 782133;
(3) 782108;
(4) 781359
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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-1851-2024 - 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
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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-1852-2024 - Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781358
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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-1853-2024 - Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781295
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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-1854-2024 - MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF):
(1) 782152
(2) 782110
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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-1855-2024 - Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781350
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2
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05/17/2024
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Philips North America Llc
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