BEUDAMED
    357 results · 13ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    Ingenia 3.0T, Magnetic Resonance System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·March 12, 2024

    SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·March 12, 2024

    Intera 1.5T Power/Pulsar, Magnetic Resonance System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·March 12, 2024

    Achieva 3.0T, Magnetic Resonance System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·March 12, 2024

    Intera 1.5T Achieva IT Nova, Magnetic Resonance System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·March 12, 2024

    Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    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

    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

    SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·June 4, 2021

    SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·June 4, 2021

    Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·June 4, 2021

    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021