BEUDAMED
    41 results · 76ms · Sources: EU EUDAMED, US FDA

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    Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·December 24, 2025

    Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel·Product code KPS·September 12, 2025

    GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

    GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

    GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022