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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 36 Results
510(K) Number: K163331
 
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GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System 2 08/13/2025 GE Medical Systems, LLC
GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System 2 08/13/2025 GE Medical Systems, LLC
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System 2 08/13/2025 GE Medical Systems, LLC
GE Signa Artist, Nuclear Magnetic Resonance Imaging System 2 08/13/2025 GE Medical Systems, LLC
GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System 2 08/13/2025 GE Medical Systems, LLC
SIGNA Architect 2 07/18/2025 GE Medical Systems, LLC
SIGNA Architect, Nuclear Magnetic Resonance Imaging System 2 11/22/2024 GE Medical Systems, LLC
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System 2 11/22/2024 GE Medical Systems, LLC
Discovery MR750w 3.0T, whole body magnetic resonance scanner 2 11/22/2024 GE Medical Systems, LLC
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0... 2 08/02/2024 GE Medical Systems, LLC
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