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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 35 Results
510(K) Number: K213516
 
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Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; 2 07/30/2025 Philips North America
MR 7700 Model Numbers (REF): (1) 782120, (2) 782153; 2 07/30/2025 Philips North America
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
Intera 1.0T Omni/Stellar, Model Number: 781102; 2 05/15/2025 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.5T Master/Nova, Model Number: 781106; 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.
Enterprise 1.5T, Model Number: 781145; 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
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