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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 15 Results
510(K) Number: K132376
 
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GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System 2 08/13/2025 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
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR... 2 02/09/2022 GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, ... 2 02/09/2022 GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, ... 2 02/09/2022 GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System,... 2 02/09/2022 GE Healthcare, LLC
Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body... 2 08/02/2017 GE Medical Systems, LLC
Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonanc... 2 08/02/2017 GE Medical Systems, LLC
Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic... 2 08/02/2017 GE Medical Systems, LLC
Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonan... 2 08/02/2017 GE Medical Systems, LLC
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