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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 26 Results
510(K) Number: K213516
 
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Ingenia 3.0T CX, Model (REF) Numbers 781271, 782105 2 02/01/2024 Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartP... 2 08/11/2023 Philips North America
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 2 08/11/2023 Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartP... 2 08/11/2023 Philips North America
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106 2 08/11/2023 Philips North America
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional imag... 2 09/20/2024 Philips North America Llc
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, sp... 2 09/20/2024 Philips North America Llc
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, sp... 2 09/20/2024 Philips North America Llc
MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/... 2 09/20/2024 Philips North America Llc
MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/... 2 09/20/2024 Philips North America Llc
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