BEUDAMED
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    GE Healthcare, Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer, and Cellular Viewer WIT with L-WEB05 software. GE Healthcare 8200 West Tower Avenue, Milwaukee, WI 53223 Mobile Care Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda network or Unity Network and Web Viewer clients. Web Viewer can be used for viewing or otherwise processing information from several bedside monitors or other networked devices. Pocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other network devices. Cellular Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices.

    FDA Recall
    Terminated ·GE Healthcare Kuortaaneenkatu 2 Helsinki Finland·Product code MSX·July 16, 2008

    Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.

    FDA Recall
    Terminated ·Spacelabs Healthcare Inc·Product code MSX·January 17, 2018

    Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code MSX·November 28, 2012

    Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.

    FDA Recall
    Terminated ·Datascope Corp·Product code MSX·April 5, 2004

    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code MSX·May 12, 2011

    Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx 01 with N-DISVENT 02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is intended for use by qualified medical personnel only.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MSX·May 8, 2009

    S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, GE Healthcare, Wauwatosa, WI 53226.

    FDA Recall
    Terminated ·GE Healthcare·Product code MSX·December 13, 2007

    DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and iCentral (including iCentral Client)) The Datex-Ohmeda Network and iCentral (including iCentral Client) transfers information between networked Datex-Ohmeda devices in the Monitor Network as well as between Monitor Network and networked devices in GE Unity NetworkTM. It also allows information transfer between several iCentrals. Within one Monitor Network it allows a networked device to display, store, print and otherwise process information received from other networked devices. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Monitor Network. Network connections consist of hardwired network cables and/or Wireless LAN (WLAN) connections. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda Network, between the Datex-Ohmeda Network and devices in GE Unity Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS). The iCentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The iCentral Client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is for use by qualified personnel only.

    FDA Recall
    Terminated ·Ge Healthcare, Llc·Product code MSX·June 25, 2010

    Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry Step-down and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values which as heart rate and systolic, mean and diastolic pressure. This device acts as the Central Monitor Station, it permits from one (1) to sixteen (16) bedside monitor(s) to be connected simultaneously.

    FDA Recall
    Terminated ·Vidco, Inc.·Product code MSX·November 8, 2015

    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 Recall
    Terminated ·Visicu, Inc.·Product code MSX·March 27, 2015

    Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is 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. The eCareManager system provides patient information and surveillance of monitored patients at the point of care location and at a remote, supplementary care location through wide area networking technology and dedicated phone lines and is solely intended for use in a hospital environment. It is not intended to be used in a home environment.

    FDA Recall
    Terminated ·Visicu, Inc.·Product code MSX·February 22, 2012

    PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code MSX·February 27, 2004

    3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code MSX·May 27, 2021

    Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).

    FDA Recall
    Terminated ·Ascom US, INC.·Product code MSX·December 10, 2015

    GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and L-NETC05, Datex-Ohmeda Inc., PO Box 7550 Madison, WI 53707-7550, USA, GE Healthcare Finland Oy, Helsinki, Finland PO Box 900. FI-00031 GE. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other network devices in Monitor Network. Network connection consists of hardwire network and/or wireless LAN (WLAN) connection. The iCentral can be used for remote monitor management, storage, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other network devices. The Dates-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is to be used by qualified personnel only.

    FDA Recall
    Terminated ·GE Healthcare·Product code MSX·January 26, 2009

    eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. Model Number: 865325

    FDA Recall
    Terminated ·Philips North America Llc·Product code MSX·January 3, 2022

    TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code MSX·July 14, 2017

    Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code MSX·September 28, 2017

    Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl Sm-RNP [CF] .asy ZEUS vl Sm-RNP [CV].asy ZEUS vl CMV lgG.asy ZEUS vl CMV lgM.asy ZEUS vl EBV-VCA lgG.asy ZEUS vl EBV-VCA lgM.asy ZEUS vl H. pylori lgG.asy ZEUS vl M. pneumoniae lgG.asy ZEUS vl M. pneumoniae lgM.asy ZEUS vl Measles lgG.asy ZEUS vl Mumps lgG .asy ZEUS vl T. gondii lgG .asy ZEUS vl T. gondii lgM.asy ZEUS vl VZV lgG.asy ZEUS vl Rubella lgG .asy ZEUS vl Rubella lgM.asy ZEUS vl MPO [CF].asy ZEUS vl MPO [CV].asy ZEUS vl EBNA-1 lgG.asy ZEUS vl.1 HSV-1 and 2 lgM.asy Product Usage: The DYNEX DSX Automated ELISA System is an open automated open system to perform ELISA immunoassay

    FDA Enforcement
    Class II ·Terminated·Zeus Scientific, Inc.·September 18, 2019

    GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code KPS·May 19, 2017