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    FDA UDI
    Brainlab SE·04056481006464·

    CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc·May 11, 2016

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·August 6, 2020

    CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.

    FDA Recall
    Terminated ·Carestream Health Inc·Product code LLZ·April 15, 2016

    SYMPHONY

    FDA Adverse Event
    Injury ·SORIN CRM·Product code NVZ·December 7, 2018

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·October 24, 2019

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·September 15, 2021

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·October 8, 2024

    NIM® 3.0 MAINFRAME INTERNATIONAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·February 25, 2025

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·June 14, 2021

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·November 16, 2022

    NIM VITAL¿ CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·June 6, 2025

    NUC 4 OS IMG IOT10/EPI 4.0

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JQP·April 18, 2023

    NUC 4 OS IMG IOT10/EPI 4.0

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JQP·February 16, 2023

    NUC 4 OS IMG IOT10/EPI 4.0

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JQP·April 19, 2023

    NUC 4 OS IMG IOT10/EPI 4.0

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JQP·April 28, 2023

    NUC 4 OS IMG IOT10/EPI 4.0

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·November 19, 2024

    NUC 4 OS IMG IOT10/EPI 4.0

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JQP·December 29, 2022

    NIM 4.0 PATIENT INTERFACE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 1, 2023

    POWER SUPPLY (FIXED HEADS )

    FDA Adverse Event
    Malfunction ·Q CORE MEDICAL LTD.·Product code MRZ·January 13, 2016