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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 8 of 8 Results
510(K) Number: K132376
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GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System 2 08/13/2025 FEI # 2183553
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 FEI # 2183553
GE Medical Systems, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System,... 2 02/09/2022 FEI # 2126677
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, ... 2 02/09/2022 FEI # 2126677
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, ... 2 02/09/2022 FEI # 2126677
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR... 2 02/09/2022 FEI # 2126677
GE Healthcare, LLC
Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high r... 2 02/10/2017 FEI # 2126677
GE Healthcare, LLC
GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1... 2 11/10/2015 FEI # 2126677
GE Healthcare
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