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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 5 of 5 Results
510(K) Number: K183231
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SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0,... 2 08/02/2024 GE Medical Systems, LLC
SIGNA Premier magnetic resonance scanner, model 5748519. 2 07/21/2022 GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclea... 2 02/09/2022 GE Healthcare, LLC
SIGNA Premier nuclear magnetic resonance imaging system 2 10/16/2021 GE Healthcare, LLC
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high r... 2 07/12/2021 GE Healthcare, LLC
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