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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 14 Results
510(K) Number: K143251
 
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SIGNA Creator, SIGNA Explorer, NMRI systems 2 02/28/2025 GE Healthcare (China) Co., Ltd.
SIGNA MR355, SIGNA MR360, NMRI system 2 02/28/2025 GE Healthcare (China) Co., Ltd.
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, M... 2 08/02/2024 GE Medical Systems, LLC
SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging Sy... 2 08/02/2024 GE Medical Systems, LLC
SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging Sy... 2 08/02/2024 GE Medical Systems, LLC
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Ma... 2 08/02/2024 GE Medical Systems, LLC
SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, M... 2 08/02/2024 GE Medical Systems, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explo... 2 02/09/2022 GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 S... 2 02/09/2022 GE Healthcare, LLC
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system 2 10/16/2021 GE Healthcare, LLC
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