BEUDAMED
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    BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. It is only used in hospital or clinical settings or emergency response environments.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DQA·February 27, 2008

    BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DQA·July 18, 2007

    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

    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

    McKesson Radiology-PACS. McKesson Radiology is a medical image and information 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·May 21, 2014

    BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DXN·April 2, 2008

    Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code BTL·December 5, 2005

    BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code MWI·June 5, 2007

    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 Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). 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 Imaging Group·September 28, 2016

    NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; USA EPMedSystems, Inc. Cooper Run Executive Park, 575 Route 73 North, Unit D, West Berlin, NJ 08090. Outer box labeled as Smiths Medical. The NurseMate Remote Review Station is an integrated review station for the EP WorkMate Computer recording system that allows a separate user to review and edit patient study date stored on the SP Work Mate System and monitor patient data from the EP WorkMate during a Patient study.

    FDA Recall
    Terminated ·St. Jude Medical·Product code DQK·February 13, 2009

    Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 24, 2016

    The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.

    FDA Enforcement
    Class II ·Terminated·Visicu, Inc.·December 16, 2015

    BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys (on/off, waveform/trend, alarm silence, menu/enter, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DQA·November 6, 2006

    9200 Advisor Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 Main St., Westfield, PA 16950).

    FDA Recall
    Terminated ·Smiths Medical PM, Inc. N7·Product code CCK·January 15, 2010

    8400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main St, Westfield, PA 16950) for its battery charger 330.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc. N7·Product code CCK·January 15, 2010

    BCI 3180 Pulse Oximeter uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 E. Main St., Westfield, PA 16950).

    FDA Recall
    Terminated ·Smiths Medical PM, Inc. N7·Product code DQA·January 15, 2010

    DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 8, 2017

    All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.

    FDA Enforcement
    Class II ·Terminated·Hyperion Medical·August 27, 2014

    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·September 13, 2017