BEUDAMED
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    Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Immaging·August 6, 2014

    Horizon Medical Imaging, Picture Archive Communication System (PACS).

    FDA Enforcement
    Class II ·Terminated·Mckesson Information Solutions LLC·February 19, 2014

    Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Immaging·June 18, 2014

    McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.

    FDA Enforcement
    Class II ·Terminated·Mckesson Information Solutions LLC·October 9, 2013

    McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.

    FDA Recall
    Terminated ·Mckesson Medical Immaging Suite 130-10711 Cambie Road Richmond Canada British Columbia·Product code LLZ·February 18, 2016

    McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Immaging·March 23, 2016

    Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR KIT

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·July 29, 2015

    McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.

    FDA Recall
    Terminated ·Mckesson Information Solutions LLC·Product code LLZ·September 4, 2013

    Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR KIT

    FDA Recall
    Terminated ·Covidien LLC·Product code FSY·April 16, 2015

    MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·April 24, 2013

    Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

    FDA Recall
    Terminated ·Mckesson Information Solutions LLC·Product code LLZ·February 2, 2011

    Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Imaging Group·August 29, 2012

    MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.

    FDA Enforcement
    Class II ·Terminated·Maquet Medical Systems USA·November 6, 2013

    MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DTQ·March 7, 2013

    Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

    FDA Recall
    Terminated ·Mckesson Medical Immaging Suite 130-10711 Cambie Road Richmond Canada British Columbia·Product code LLZ·May 5, 2014

    MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.

    FDA Recall
    Terminated ·Maquet Medical Systems USA·Product code DTQ·September 12, 2013

    BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)

    FDA Recall
    Terminated ·Becton Dickinson and Company·Product code HMY·August 9, 2007

    BD K-3000 Microkeratome Blade REF 378607

    FDA Recall
    Terminated ·BD Opthalmic Systems·Product code HMY·January 24, 2003

    Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016