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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 20 of 35 Results
510(K) Number: K213516
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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
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153; 2 05/16/2025 Philips North America Llc
Product Name: Upgrade to MR 7700; Model Number: 782130; 2 05/16/2025 Philips North America Llc
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
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic im... 2 09/20/2024 Philips North America Llc
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