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U.S. Department of Health and Human Services

Medical Device Recalls
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31 to 37 of 37 Results
510(K) Number: K213516
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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 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, Model Number: 782146; 2 05/15/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SmartPath to dStream for 3.0T, Model Number: 782145; 2 05/15/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
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
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