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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 6 of 6 Results
510(K) Number: K142098
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GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Res... 2 08/13/2025 GE Medical Systems, LLC
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA... 2 11/22/2024 GE Medical Systems, LLC
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic ... 2 08/02/2024 GE Medical Systems, LLC
Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonan... 2 08/02/2017 GE Medical Systems, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomograp... 2 02/09/2022 GE Healthcare, LLC
GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic reso... 2 11/10/2015 GE Healthcare
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