BEUDAMED
    296 results · 35ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Open, Classified ×

    GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·August 5, 2024

    GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Recall
    Open, Classified ·GE Medical Systems Information Technologies Inc·Product code MHX·April 24, 2026

    GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Recall
    Open, Classified ·GE Medical Systems Information Technologies Inc·Product code MHX·April 24, 2026

    GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Recall
    Open, Classified ·GE Medical Systems Information Technologies Inc·Product code MHX·April 24, 2026

    GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Recall
    Open, Classified ·GE Medical Systems Information Technologies Inc·Product code MHX·April 24, 2026

    GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Recall
    Open, Classified ·GE Medical Systems Information Technologies Inc·Product code MHX·April 24, 2026

    GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    FDA Recall
    Open, Classified ·GE Medical Systems Information Technologies Inc·Product code MHX·April 24, 2026

    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

    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