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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 17 Results
510(K) Number: K162931
 
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SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a... 2 09/03/2021 FEI # 3016618143
Philips North America Llc
Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113; 2 05/16/2025 FEI # 3016618143
Philips North America Llc
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145 2 05/16/2025 FEI # 3016618143
Philips North America Llc
Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146 2 05/16/2025 FEI # 3016618143
Philips North America Llc
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144; 2 05/16/2025 FEI # 3016618143
Philips North America Llc
Intera 1.5T Power/Pulsar 2 11/21/2023 FEI # 3016618143
Philips North America Llc
Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic dev... 2 08/25/2021 FEI # 3016618143
Philips North America Llc
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic de... 2 09/03/2021 FEI # 3016618143
Philips North America Llc
Ingenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging System 2 02/22/2019 FEI # 3002807880
Philips Medical Systems Nederlands
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnost... 2 08/25/2021 FEI # 3016618143
Philips North America Llc
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