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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K121676
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3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2... 2 08/02/2024 GE Medical Systems, LLC
1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, ... 2 08/02/2024 GE Medical Systems, LLC
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance I... 2 04/04/2022 GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA ... 2 02/09/2022 GE Healthcare, LLC
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system 2 10/16/2021 GE Healthcare, LLC
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System 2 07/12/2021 GE Healthcare, LLC
SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi ... 2 01/28/2020 GE Healthcare, LLC
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance ... 2 01/07/2019 GE Healthcare, LLC
1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx fa... 2 08/02/2017 GE Medical Systems, LLC
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2... 2 09/23/2013 GE Healthcare, LLC
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