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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 37 Results
510(K) Number: K213516
 
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Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1. 2 01/29/2026 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 dStream for 3.0T, Model Number: 782145; 2 05/15/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SmartPath to dStream for 1.5T, Model Number: 782146; 2 05/15/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
Product Name: Upgrade to MR 7700; Model Number: 782130; 2 05/16/2025 Philips North America Llc
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153; 2 05/16/2025 Philips North America Llc
Philips Upgrade to MR 7700 System, Model Number 782130 2 12/08/2022 Philips North America Llc
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144 2 12/08/2022 Philips North America Llc
Philips MR 7700 System, Model Number 782120 2 12/08/2022 Philips North America Llc
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