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    IntelliVue X3 Patient Monitor.

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code MHX·November 17, 2017

    Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 2014

    SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4"display VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor with 8.4" display VM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside Patient Monitor with 8.4" display or 3/5 Lead ECG, NBP, Temp, optional SPo2 option IBP Bedside Patient Monitor with 8.4" display VM8 3/5 Lead ECG, NBP, Temp, IPB, ET CO2, SPo2 Bedside Patient Monitor with 10" display or 3/5 Lead ECG, NBP, Temp, IPB, SPo2 Bedside Patient Monitor with 10" display Part number: VM3: 863077,453564041661,453564050161, VM4: 863063,453564024371,453564021961, 453564024401,453564021971 VM6: 863064,863065,453564024421,453564022001, 453564024441 VM8: 453564022041,863066,863068,453564022081, 453564024461, 453564024481 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code MHX·October 30, 2009

    Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).

    FDA Recall
    Terminated ·Suntech Medical, Inc.·Product code DXN·December 11, 2019

    Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 2014

    Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 2014

    Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 2014

    Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 2014

    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 2014

    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 2014

    GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes, but is not limited to: electrocardiogram, invasive blood pressure, noninvasive blood pressure (NBP), heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORKTM indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·June 26, 2012

    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 IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

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

    Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DXN·January 14, 2013

    VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code GKA·April 14, 2010

    Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All four model numbers have the same user manual. The device is intended for monitoring, recording and alarming of multiple physiological parameters.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MHX·April 30, 2008

    NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

    FDA Recall
    Terminated ·Product code MRN·May 3, 2023

    SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to include Predictive Temperature only; SPo2 only; SPo2 and Recorder only; SPo2 and Predictive Temperature only; or SPo2, Predictive Temperature, and Recorder Part Number: 863067 and 453564041491 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code MHX·October 30, 2009

    Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code MHX·December 19, 2014

    Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code GBZ·January 20, 2017