BEUDAMED
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    CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.

    FDA Recall
    Terminated ·LMS Medical Systems Ltd·Product code HGM·January 11, 2005

    Philips Avalon Fetal Monitor FM30; Model Number: M2703A.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code HGM·May 12, 2009

    Philips Avalon Fetal Monitor FM20; Model Number: M2702A.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code HGM·May 12, 2009

    GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Intended for use as a clinical data management system.

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code HGM·September 25, 2008

    GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is

    FDA Recall
    Terminated ·GE Medical Systems Information Technologies·Product code HGM·May 21, 2003

    Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document, annotate, display, store, print, export and retrieve patient clinical practice information. This product is intended for professional use only.

    FDA Recall
    Terminated ·GE Healthcare It·Product code HGM·March 11, 2013

    Philips Avalon Fetal Monitor FM 50 Catalog Number: M2705A.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code HGM·November 23, 2009

    Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code HGM·September 25, 2008

    Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code HGM·October 3, 2014

    Philips Avalon Fetal Monitor FM 30 Catalog Number: M2703A.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code HGM·November 23, 2009

    FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)

    FDA Recall
    Terminated ·Product code HGM·September 13, 2005

    Corometrics MODEL 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number 2024489-002. Intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms; maternal uterine activity; heart/pulse rate, blood pressure and %SP02.

    FDA Recall
    Terminated ·Datex Ohmeda, Inc. dba GE Healthcare·Product code HGM·May 5, 2008

    GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit.

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code HGM·June 30, 2008

    Philips Avalon Fetal Monitor FM 20 Catalog Number: M2702A.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code HGM·November 23, 2009

    Philips Avalon Fetal Monitor FM 40 Catalog Number: M2704A.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code HGM·November 23, 2009

    FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)

    FDA Recall
    Terminated ·Product code HGM·September 13, 2005

    BirthNet OB Data Management System 91861

    FDA Recall
    Terminated ·Spacelabs Medical Incorporated·Product code HGM·October 13, 2005

    Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Enforcement
    Class II ·Terminated·Viterion TeleHealthcare Llc·February 20, 2013

    Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012

    Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer HealthCare LLC -- Common Name: Viterion100 TeleHealth Monitor -- Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] Product Usage: The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The systems collect, accumulate and periodically transmit patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and the practitioner. The physiological monitoring instrument, selected by the healthcare practitioner, operates in conjunction with the Patient Terminal located in the patients home, a hospital room, nursing home, or other healthcare facility. The Patient Terminal connects to the server via a conventional or cellular telephone line. The system is not a real-time monitoring system, and there is no requirement that a health care professional review the information at any specific interval or provide immediate feedback to patients. Rather, the system is intended to aid the physicians longer term management of patients. Patients are expected to take the same short term actions in response to physiological data as they ordinarily would in the absence of the Tele Health Monitor.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·May 25, 2011