BEUDAMED
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    regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·October 14, 2015

    regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

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

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

    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

    GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·July 20, 2011

    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·December 16, 2013

    GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·June 13, 2014

    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·November 27, 2013

    Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS

    FDA Recall
    Terminated ·Oakworks Inc·Product code FNJ·April 21, 2022

    GE Healthcare Carescape Patient Data Module

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·September 19, 2014

    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·April 3, 2013

    PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19

    FDA Recall
    Terminated ·Oakworks Inc·Product code FNL·April 21, 2022

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code CCK·June 11, 2014

    GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·July 7, 2014

    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 MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DQK·February 2, 2009

    CARESCAPE MONITOR B850 Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·July 16, 2010

    GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP100 Hardware). The CIC Pro" clinical Information Center central station is intended to collect information from a network and display this date. This data includes physiological, patient dermographic and/or other non-medical information.

    FDA Recall
    Terminated ·GE Medical Systems Information Tecnology 9900 Inovation Drive RP 2122 3rd Floor Wauwatosa WI 53226·Product code DSI·March 10, 2009

    Power supply boards on Dash 3000, 4000 and 5000 Monitors. GE Healthcare, 8200 West Tower Avenue, Milwaukee, WI 53223.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·October 11, 2010

    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·April 3, 2013