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    HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, EGG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esosophageal/Nasopharyngeal/Tymnpanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, and functional oxygen saturation (Sp0 2) and pulse rate via continuous monitoring , including monitoring during conditions of clinical patient motion or low perfusion. K120598 (Procare Monitor B40): The PROCARE Monitor 840 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor 840 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor 840 is not intended for use during MRI. The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympaiic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion. K130584 (Monitor B40): The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy. Product Quantity Distributed (Int) 16,061 (343 US, 15,718 OUS)

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·December 18, 2013

    GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING OPTIMA CT660S PRO 32 S, CT GOLDSEAL, CT GOLDSEAL OPTIMA 660, CT GOLDSEAL OPTIMA 660 UT-BUC, CT OPTIMA 660 LNG HN P20, CT OPTIMA 660 MID HN P20, CT OPTIMA 660 PRO, CT OPTIMA 660 PRO LONG BJG P2., CT OPTIMA 660 PRO MID, CT OPTIMA 660 PRO MID HN P20, CT OPTIMA 660S LNG HN P20, CT OPTIMA CT660 GT 1700, CT OPTIMA CT660 GT1700, CT OPTIMA CT660 GT1700V, CT OPTIMA CT660 PRO GT1700, CT OPTIMA CT660 PRO LNG P1.5 H, CT OPTIMA CT660 PRO MID P1.5 H, CT OPTIMA CT660 SE GT 1700, CT OPTIMA CT660 SE GT2000, CT660, CT660 ASIR OPT, OPT CT660 FREEDOM GT1700 MKE25, OPT CT660 FREEDOM GT1700 MKE25, OPT CT660 FREEDOM GT2000 MKE25, OPTI660_A_G_1.5, OPTI660_A_L_2.0, OPTI660_N_G_1.5, OPTI660_N_G_2.0, OPTI660_N_L_2.0, OPTIMA 660 DIVA, OPTIMA 660 LNG HN P20, OPTIMA 660 LNG HN P20, OPTIMA 660 LONG, OPTIMA 660 LONG BJG P2.0, OPTIMA 660 LONG WSO, OPTIMA 660 MID, OPTIMA 660 MID BJG P1.5, OPTIMA 660 MID HN P20, OPTIMA 660 MID HN P20, OPTIMA 660 MID WSO, OPTIMA 660 PRO LGN HN P20, OPTIMA 660 PRO LONG BJG P1.5_, OPTIMA 660 PRO LONG BJG P2, OPTIMA 660 PRO LONG BJG P2.0, OPTIMA 660 PRO LONG BJG P2.0, OPTIMA 660 PRO LONG WSO, OPTIMA 660 PRO MID BJG P1.5, OPTIMA 660 PRO MID BJG P2.0, OPTIMA 660 PRO MID H, OPTIMA 660 PRO MID HN P20, OPTIMA 660 PRO MID WSO, OPTIMA 660 WSO, OPTIMA 660S 32 OPTIMA 660S 32 SLICE LONG WSO, OPTIMA 660S 32 SLICE MID WSO, OPTIMA 660S LNG HN P20, OPTIMA 660S MID BJG P2.0, OPTIMA 660S PRO 32 SLICE M WSO, OPTIMA 660S PRO LONG BJG P2.0, OPTIMA 660S PRO MID BJG P1.5, OPTIMA 660S WSO, OPTIMA CT 660 FREEDOM, OPTIMA CT660, OPTIMA CT660 2ND EDITION, OPTIMA CT660 ASIR, OPTIMA CT660 ASIR ADV 2ND, OPTIMA CT660 FREEDOM, OPTIMA CT660 FREEDOM LG BJG2.5, OPTIMA CT660 FREEDOM LG BJG2.5, OPTIMA CT660 FREEDOM LG HN2, OPTIMA CT660 FREEDOM LG HN2.5, OPTIMA CT660 FREEDOM MD, OPTIMA CT660 FREEDOM MD BJG2., OPTIMA CT660 GS, OPTIMA CT660 GT 1700 BJG2, OPTIMA CT660 GT 1700 BJG2.5, OPTIMA CT660 GT 1700 HN P2, OPTIMA CT660 GT 1700 HN P2., OPTIMA CT660 GT 1700 HN P2.5, OPTIMA CT660 GT 2000 HN P2.5, OPTIMA CT660 GT1700, OPTIMA CT660 GT1700 MKE2.5, OPTIMA CT660 GT1700 PHASE 1.5, OPTIMA CT660 GT2000, OPTIMA CT660 GT2000, OPTIMA CT660 GT2000 PHASE 1.5, OPTIMA CT660 LITE, OPTIMA CT660 LITE HN P2.5, OPTIMA CT660 MID P1.5 HINO, OPTIMA CT660 MID P20, OPTIMA CT660 MID P2000, OPTIMA CT660 PRO, OPTIMA CT660 PRO GT 2000, OPTIMA CT660 PRO GT1700, OPTIMA CT660 PRO GT1700 ASIR, OPTIMA CT660 PRO GT1700 P20, OPTIMA CT660 PRO GT1700 PHASE, OPTIMA CT660 PRO GT1700 PHASE 1.5, OPTIMA CT660 PRO GT1700V, OPTIMA CT660 PRO GT1700V ASIR, OPTIMA CT660 PRO GT2000, OPTIMA CT660 PRO GT2000 PHASE, OPTIMA CT660 PRO GT2000 PHASE 1.5, OPTIMA CT660 PRO LNG, OPTIMA CT660 PRO LNG P1.5, OPTIMA CT660 PRO LNG P1.5 HINO, OPTIMA CT660 PRO LNG P1.5 HINO, OPTIMA CT660 PRO LONG BJG P2.0, OPTIMA CT660 PRO LONG P2.0, OPTIMA CT660 PRO MID P1.5, OPTIMA CT660 PRO MID P1.5 H, OPTIMA CT660 PRO MID P1.5 HINO, OPTIMA CT660 SE, OPTIMA CT660 SE GT 1700 BJG, OPTIMA CT660 SE GT 1700 BJG2.5, OPTIMA CT660 SE GT 1700 BJG2.5, OPTIMA CT660 SE GT 1700 HN2, OPTIMA CT660 SE GT 2000, OPTIMA CT660 SE GT 2000 BJG, OPTIMA CT660 SE GT 2000 BJG2., OPTIMA CT660 SE GT 2000 BJG2.5, OPTIMA CT660 SE GT 2000 HN2, OPTIMA CT660 SE GT 2000 HN2.5, OPTIMA CT660 SE GT2000 MKE2.5, OPTIMA CT660 SE WITH ASIR, OPTIMA CT660 W/PRO PKG-BR, OPTIMA CT660 W/PRO PKG-LA, OPTIMA CT660-64 USA, OPTIMA CT660S, OPTIMA CT660S, OPTIMA CT660S 32 SLICE GT1700, OPTIMA CT660S 32 SLICE HINO, OPTIMA CT660S GT, OPTIMA CT660S GT 1700 HN2.5, OPTIMA CT660S GT 2000, OPTIMA CT660S GT 2000 BJG2.5, OPTIMA CT660S GT 2000 HN2.5, OPTIMA CT660S GT1700 BJG P2.5, OPTIMA CT660S GT1700 HN P2.5, OPTIMA CT660S PRO 32 HINO, OPTIMA CT660S PRO 32 SLICE, OPTIMA CT660S PRO 32 SLICE GT2, OPTIMA CT660S PRO P1.5 HINO, OPTIMACT660_A_G, OPTIMACT660_A_L, OPTIMACT660_N_G, OPTIMACT660_N_L, REVOLUTION EVO, REVOLUTION EVO WITH GT2000 TABLE (H

    FDA Enforcement
    Class II ·Terminated·GE Healthcare Japan Corporation·August 29, 2018

    (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·August 31, 2022

    Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·October 14, 2015

    GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·October 31, 2018

    GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·October 2, 2013

    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·July 18, 2012

    Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·August 21, 2013

    Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·November 28, 2012

    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·March 11, 2026

    GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·April 9, 2025

    GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·April 9, 2025

    GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·April 9, 2025

    GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900, 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-02347996, 423834-Centricity Universal Viewer Zero Footprint / ZFP-02286658, 1407636-Centricity Universal Viewer Zero Footprint / ZFP-02304121, 651240-Centricity Universal Viewer Zero Footprint / ZFP-02173181, 268034-Centricity Universal Viewer Zero Footprint / ZFP-02402520; 3) 2089507-098, JP-310027-Centricity Universal Viewer Zero Footprint / ZFP-02033125; 4) 2089507-109, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095312, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095313, 327750-Centricity Universal Viewer Zero Footprint / ZFP-02184508; 5) 2089507-111, 105468-1-Centricity Universal Viewer Zero Footprint / ZFP-02254840, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-00096090, JP-340111-Centricity Universal Viewer Zero Footprint / ZFP-01275379, JP-275353-Centricity Universal Viewer Zero Footprint / ZFP-02042636; 6) 2089507-112, 3922-25-Centricity Universal Viewer Zero Footprint / ZFP-01290685, 3922-17-Centricity Universal Viewer Zero Footprint / ZFP-00098229, 1503586-Centricity Universal Viewer Zero Footprint / ZFP-21016603, RU0994-Centricity Universal Viewer Zero Footprint / ZFP-02331255; 7) 2089507-114, 1461-1-Centricity Universal Viewer Zero Footprint / ZFP-02360229, 1461-1-Centricity Universal Viewer Zero Footprint / ZFP-01803680, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225897, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225898, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225904, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01371500, M51725-Centricity Universal Viewer Zero Footprint / ZFP-01300873, M1781854-Centricity Universal Viewer Zero Footprint / ZFP-01553772, 609334-Centricity Universal Viewer Zero Footprint / ZFP-01282257, UJJF01-Centricity Universal Viewer Zero Footprint / ZFP-22186138, CMC-Centricity Universal Viewer Zero Footprint / ZFP-01820241, JP-100014-Centricity Universal Viewer Zero Footprint / ZFP-01890709, KW1102-Centricity Universal Viewer Zero Footprint / ZFP-02191178, 59219_ERPerror-Centricity Universal Viewer Zero Footprint / ZFP-02327073, QA1114-Centricity Universal Viewer Zero Footprint / ZFP-02306397, SAU1433-Centricity Universal Viewer Zero Footprint / ZFP-01457278, TTSH-CVIS-Centricity Universal Viewer Zero Footprint / ZFP-02041523, NE4651-Centricity Universal Viewer Zero Footprint / ZFP-00038599, NE6703-Centricity Universal Viewer Zero Footprint / ZFP-00038552, NE6731-Centricity Universal Viewer Zero Footprint / ZFP-00038461, NE3006-Centricity Universal Viewer Zero Footprint / ZFP-00038362, NE2196-Centricity Universal Viewer Zero Footprint / ZFP-00038588, NPV738-Centricity Universal Viewer Zero Footprint / ZFP-00038637, NE2031-Centricity Universal Viewer Zero Footprint / ZFP-00038578, NE7405-Centricity Universal Viewer Zero Footprint / ZFP-00038372, NE2162-Centricity Universal Viewer Zero Footprint / ZFP-00038563, NE4878-

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·November 13, 2024

    GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·October 2, 2024

    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·September 25, 2024

    GE Healthcare, Proteus XR/a with wall stand model number 600-0301.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·January 21, 2015

    GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or 2028038-008 Also Field Replaceable Unit P/Ns 408930-001, 408930-002 Product Usage: Used for Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·March 25, 2015

    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·April 1, 2015

    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·May 6, 2015