BEUDAMED
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    CARELINK SMARTSYNC COMMON APP IOS

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code OSR·June 27, 2025

    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·June 4, 2014

    CS300

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR·Product code DSP·July 16, 2014

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·April 21, 2025

    CARELINK SMARTSYNC COMMON APP IOS

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTC·June 30, 2025

    ALLURA XPER FD

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·July 16, 2024

    ALLURA XPER FD

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·September 12, 2024

    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·April 30, 2014

    ALLURA XPER FD10

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code IZI·October 7, 2024

    HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·ACCRIVA DIAGNOSTICS·Product code JPA·March 2, 2018

    CARELINK SMARTSYNC COMMON APP IOS

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code OSR·October 16, 2025

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·July 7, 2025

    HEMOSPHERE ALTA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DQE·September 24, 2025

    EPIQ CVXI

    FDA Adverse Event
    Death ·PHILIPS ULTRASOUND, INC·Product code IYN·May 6, 2025

    EPIQ CVXI

    FDA Adverse Event
    Death ·PHILIPS ULTRASOUND, INC·Product code IYN·May 6, 2025

    CARELINK SMARTSYNC COMMON APP IOS

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTC·June 18, 2025

    STELLANT DUAL CT INJECTOR

    FDA Adverse Event
    Death ·BAYER MEDICAL CARE, INC.·Product code DXT·April 20, 2016

    3mensio Workstation (Vascular Fenestrated) software

    FDA Enforcement
    Class II ·Ongoing·PIE Medical Imaging B.V.·August 20, 2025

    CARELINK SMARTSYNC COMMON APP IOS

    FDA Adverse Event
    Malfunction ·MEDTRONIC INC·Product code OSR·July 8, 2025

    LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·March 16, 2016