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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: K202966
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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 AIR, Nuclear Magnetic Resonance Imaging System 2 11/22/2024 GE Medical Systems, LLC
SIGNA Architect, Nuclear Magnetic Resonance Imaging System 2 11/22/2024 GE Medical Systems, LLC
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV2... 2 08/02/2024 GE Medical Systems, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nucle... 2 02/09/2022 GE Healthcare, LLC
SIGNA Architect nuclear magnetic resonance imaging system 2 10/16/2021 GE Healthcare, LLC
SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high... 2 07/12/2021 GE Healthcare, LLC
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