BEUDAMED
    121 results · 44ms · Sources: EU EUDAMED, US FDA

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    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 14, 2024

    SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 14, 2024

    SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code OUO·June 14, 2024

    Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 14, 2024

    Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code FMZ·May 1, 2026

    GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 20, 2025

    GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 20, 2025

    Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659-014, 5826659-016, 5826659-013

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LLZ·January 30, 2026

    GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code JAK·February 18, 2025

    Discovery XR656HD. X-Ray imaging system.

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code KPR·January 28, 2025

    Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 14, 2024

    SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 14, 2024

    GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code IZL·November 25, 2024

    SIGNA PET/MR

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·May 23, 2025

    GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 20, 2025

    GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 20, 2025

    GE Healthcare Revolution CT, System, X-ray, Tomography, Computed

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code JAK·February 18, 2025

    Allia IGS 5 Pulse angiographic X-ray system

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code OWB·April 20, 2026

    Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code FMZ·May 1, 2026