BEUDAMED
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    LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY

    FDA Adverse Event
    Injury ·LIFEWATCH SERVICES, INC.·Product code DSI·March 26, 2020

    LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY

    FDA Adverse Event
    Injury ·LIFEWATCH SERVICES, INC.·Product code DSI·May 14, 2020

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·October 29, 2012

    LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY)

    FDA Adverse Event
    Injury ·LIFEWATCH SERVICES, INC.·Product code DSI·February 12, 2021

    MCT 3L: UNIVERSAL GATEWAY

    FDA Adverse Event
    Injury ·LIFEWATCH SERVICES, INC.·Product code DSI·January 7, 2022

    LIFEWATCH MCT 3L: UNIVERSAL GATEWAY

    FDA Adverse Event
    Injury ·LIFEWATCH SERVICES, INC.·Product code DSI·November 29, 2021

    LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY)

    FDA Adverse Event
    Injury ·Product code DSI·November 4, 2021

    ACT 3-LEAD MCT

    FDA Adverse Event
    Injury ·LIFEWATCH SERVICES, INC.·Product code DSI·March 5, 2022

    UNKNOWN CORFLO NASOGASTRIC TUBE

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code KNT·March 10, 2026

    UNKNOWN CORFLO NASOGASTRIC TUBE

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code KNT·March 10, 2026

    UNKNOWN CORFLO NASOGASTRIC TUBE

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code KNT·March 10, 2026

    LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY)

    FDA Adverse Event
    Injury ·LIFEWATCH SERVICES, INC.·Product code DSI·October 26, 2021

    LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY)

    FDA Adverse Event
    Injury ·LIFEWATCH SERVICES, INC.·Product code DSI·November 4, 2021

    MCT 3L: UNIVERSAL GATEWAY

    FDA Adverse Event
    Injury ·LIFEWATCH SERVICES, INC.·Product code DSI·February 25, 2022

    MCT 3L: UNIVERSAL GATEWAY

    FDA Adverse Event
    Injury ·LIFEWATCH SERVICES, INC.·Product code DSI·February 23, 2022

    LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR

    FDA Adverse Event
    Injury ·BRAEMAR MANUFACTURING, LLC·Product code DSI·August 29, 2019

    Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. (b) Biograph mCT S(40)-4R, Material Number 10248671 (c) Biograph mCT S(64)-4R, Material Number 10248672 (d) Biograph mCT X-4R, Material Number 10248670 (e) Biograph mCT X-3R, Material Number 10248673 (f) BIOGRAPH mCT 20 Excel, Material Number 10507786 (g) Biograph mCT Flow Edge-4R, Material Number 10528955 (h) Biograph mCT S(40)-3R, Material Number 10248668 (i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 (j) Biograph mCT Flow 40-4R, Material Number 10529159 (k) Biograph mCT-X w/TrueV Upgrade, Material Number 10250745

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·June 27, 2018

    LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR

    FDA Adverse Event
    Injury ·LIFEWATCH SERVICES, INC.·Product code DSI·March 11, 2020

    LIFEWATCH MOBILE CARDIAC TELEMETRY 1 LEAD PATCH

    FDA Adverse Event
    Injury ·BRAEMAR MANUFACTURING, LLC·Product code DSI·June 27, 2019

    Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. (b) Biograph mCT S(40)-4R, Material Number 10248671 (c) Biograph mCT S(64)-4R, Material Number 10248672 (d) Biograph mCT X-4R, Material Number 10248670 (e) Biograph mCT X-3R, Material Number 10248673 (f) BIOGRAPH mCT 20 Excel, Material Number 10507786 (g) Biograph mCT Flow Edge-4R, Material Number 10528955 (h) Biograph mCT S(40)-3R, Material Number 10248668 (i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 (j) Biograph mCT Flow 40-4R, Material Number 10529159 (k) Biograph mCT-X w/TrueV Upgrade, Material Number 10250745

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code JAK·May 29, 2018