Computer, Diagnostic, Pre-Programmed, Single-Function
FDA product code DXG · Class II (moderate risk) · 21 CFR 870.1435 · Cardiovascular
177510(k) clearances
0PMA approvals
8recalls
Manufacturers
- Edwards Lifesciences, LLC 11
- Pulsion Medical Systems AG 8
- Lidco, Ltd. 7
- Hewlett-Packard Co. 6
- Transonic Systems, Inc. 5
- Gould, Inc. 4
- Honeywell, Inc. 4
- Electro-Catheter Corp. 4
- Abbott Laboratories 4
- Mennen Medical, Inc. 4
- American Edwards Laboratories 4
- Cheetah Medical, Inc. 3
- Baxter Healthcare Corp 3
- Nihon Kohden America, Inc. 3
- Life Sciences Manufacturing, Inc. 3
- Edwards Laboratories 3
- Dextra Medical, Inc. 2
- Critikon Company, LLC 2
- Waters Assoc., Inc. 2
- Cherne Industries, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253092 | Argos Infinity (Rev. 1.0)DXG · Traditional | Retia Medical Systems, Inc. | 02/13/2026SE |
| K251275 | VitalStream ART Connect; VitalStream-HemoDXG · Traditional | Caretaker Medical | 09/26/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | Icu Medical | 12/20/2023SE |
| K212529 | Hypotension Decision Assist Model HDA-OR2DXG · Special | Directed Systems, Ltd. | 11/23/2021SE |
| K192169 | PulsioFlex Monitoring System with ProAQT SensorDXG · Traditional | Pulsion Medical Systems SE | 04/30/2020SE |
| K193179 | EV1000 Clinical PlatformDXG · Special | Edwards Lifesciences, LLC | 12/17/2019SE |
| K190955 | Hypotension Decision AssistDXG · Traditional | Directed Systems, Ltd. | 11/27/2019SE |
| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
| K172259 | PulsioFlex Monitoring SystemDXG · Traditional | Pulsion Medical Systems SE | 01/18/2018SE |
| K163334 | LiDCOunity v2 Hemodynamic MonitorDXG · Traditional | Lidco, Ltd. | 06/05/2017SE |
| K152935 | LiDCOunity MonitorDXG · Traditional | Lidco, Ltd. | 03/17/2016SE |
| K134051 | Transonic Elsa SystemDXG · Traditional | Transonic Systems, Inc. | 01/29/2015SE |
| K134035 | Transonic HCM 103 SystemDXG · Traditional | Transonic Systems, Inc. | 09/17/2014SE |
| K140017 | Transonic HCM 102 SystemDXG · Traditional | Transonic Systems, Inc. | 09/16/2014SE |
| K132892 | Tebco-WDXG · Traditional | Bomed, Inc. | 08/01/2014SE |
| K131892 | EV1000 Clinical PlatformDXG · Traditional | Edwards Lifesciences, LLC | 05/22/2014SE |
| K131588 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; Vigileo Apco/Oximetry MonitorDXG · Traditional | Edwards Lifesciences, LLC | 05/22/2014SE |
| K132528 | E-Picco Continuous Cardiac Output Module and AccessoriesDXG · Traditional | GE Healthcare Finland Oy | 01/16/2014SE |
| K122400 | Cardiox Flow Detection SystemDXG · Traditional | Cardiox Corp. | 11/05/2013SE |
| K131048 | Lidco Cnap ModuleDXG · Traditional | Lidco, Ltd. | 08/28/2013SE |
| K122247 | Lidcorapid V2 MonitorDXG · Traditional | Lidco, Ltd. | 03/20/2013SE |
| K113821 | Transonic Costatus Cardiac Output SystemDXG · Traditional | Transonic Systems, Inc. | 09/07/2012SE |
| K122121 | Pulsioflex Monitoring System with Picco ModuleDXG · Special | Pulsion Medical Systems SE | 08/02/2012SE |
| K112448 | PulsioflexDXG · Special | Pulsion Medical Systems, Inc. | 09/22/2011SE |
| K110597 | EV1000 Clinical PlatformDXG · Traditional | Edwards Lifesciences | 06/14/2011SE |
| K103094 | Vigileo Arterial Pressure Cardiac Output / Oximetry Monitor; Vigileo Apco / Oximetry…DXG · Traditional | Edwards Lifesciences, LLC | 05/17/2011SE |
| K100709 | EV1000 Platform Model: EV1000A, EV1000DB, EV1000MDXG · Traditional | Edwards Lifesciences, LLC | 12/07/2010SE |
| K101487 | Cheetah Nicom SystemDXG · Abbreviated | Cheetah Medical, Inc. | 07/02/2010SE |
| K091786 | Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable Probes (PV2022-30…DXG · Traditional | Pulsion Medical Systems AG | 06/18/2010SE |
| K092219 | Navigator Clinical Guidence SystemDXG · Traditional | Applied Physiology Pty , Ltd. | 05/12/2010SE |
| K082308 | Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorDXG · Traditional | Edwards Lifesciences, LLC | 12/09/2008SE |
| K080116 | Transonic Costatus Cardiac Output SystemDXG · Traditional | Transonic Systems, Inc. | 09/08/2008SE |
| K081776 | Continuous Cardiac Ouput Monitor, TruccomDXG · Special | Omega Critical Care Limited | 07/22/2008SE |
| K071631 | Nicom ElectrodesDXG · Traditional | Cheetah Medical, Inc. | 01/18/2008SE |
| K073113 | Infinity Picco Pod, Model MS16734DXG · Traditional | Draeger Medical Systems, Inc. | 01/03/2008SE |
| K072735 | Pulsion PICCO-2, Model 8500DXG · Special | Pulsion Medical Systems AG | 10/18/2007SE |
| K062134 | Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorDXG · Special | Edwards Lifesciences, LLC | 08/22/2006SE |
| K060898 | Pulsion Picco Plus, Model 8100DXG · Traditional | Pulsion Medical Systems AG | 07/25/2006SE |
| K060660 | EW200 System (Oxygen Saturation Monitoring System) and Presep Oximetry CatheterDXG · Traditional | Edwards Lifesciences, LLC | 04/25/2006SE |
| K043103 | Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor, Model VIG2DXG · Special | Edwards Lifesciences, LLC | 12/09/2004SE |
| K042144 | NicomDXG · Traditional | Cheetah Medical, Inc. | 11/12/2004SE |
| K040287 | Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume…DXG · Traditional | Edwards Lifesciences, LLC | 04/26/2004SE |
| K032997 | Modification to: Horizon 9000WSDXG · Special | Mennen Medical , Ltd. | 10/15/2003SE |
| K023960 | Lidcoplus Hemodynamic Monitor System, Model HM 70DXG · Special | Lidco, Ltd. | 01/09/2003SE |
| K021874 | Abbott Q2 Plus S02/CONTINUOUS Cardiac Output Computer, List Number 56711DXG · Traditional | Abbott Laboratories | 07/12/2002SE |
| K010049 | Pulseco Hemodynamic Monitor CM71DXG · Traditional | Lidco, Ltd. | 06/14/2001SE |
| K000664 | Vigilance Cco/Cedv & Vigilance CCO/SVO2/CEDV MonitorsDXG · Traditional | Baxter Healthcare Corp | 09/20/2000SE |
| K001762 | Pulsion Continuous Pulse Contour Cardiac Output (Picco) SystemDXG · Traditional | Pulsion Medical Systems, Inc. | 06/13/2000SE |
| K991775 | Modification to Computerized Catheterization Laboratory - Horizon 9000 WSDXG · Special | Mennen Medical, Inc. | 06/24/1999SE |
| K962918 | Lidco SystemDXG · Traditional | Lidco, Ltd. | 01/08/1999SE |
| K970784 | Alexander Mfg. Rechargeable Battery (Model M3/T)DXG · Traditional | Alexander Mfg. Co. | 05/14/1997SE |
| K961661 | Oximetrix 4 Computer SystemDXG · Traditional | Abbott Laboratories | 03/04/1997SE |
| K962128 | Tebco (Thoracic Electrical Bioimpedance Cardiac Output)DXG · Traditional | Hemo Sapiens, Inc. | 11/21/1996SE |
| K955417 | Vital PakDXG · Traditional | Vital Signs, Inc. | 03/08/1996SESK |
| K946115 | Ek-View(Tm) ECG Management SystemDXG · Traditional | Apcot Medical Systems | 03/01/1995SE |
| K940415 | Horizon 9000 WSDXG · Traditional | Mennen Medical, Inc. | 01/06/1995SE |
| K943256 | Cardiac Output Option 39DXG · Traditional | Medical Data Electronics | 12/15/1994SE |
| K932414 | Continuous Cardiac Output SystemDXG · Traditional | Abbott Laboratories | 11/14/1994SE |
| K922218 | Iq SystemDXG · Traditional | Renaissance Technology, Inc. | 12/08/1992SE |
| K913358 | Midas System(Tm) 5100 Physiolog Monit/Record SystDXG · Traditional | Ppg Industries, Inc. | 12/20/1991SE |
| K902628 | Interflo Medical Model INTERFLO/1 Cardiac OutputDXG · Traditional | Biometric Research Institute, Inc. | 02/25/1991SE |
| K896930 | Cardiac Output Computer, Model COM-3DXG · Traditional | Baxter Healthcare Corp | 07/03/1990SE |
| K901926 | Sorba Model CIC-1000 W/New ElectrodesDXG · Traditional | Sorba Medical Systems, Inc. | 06/12/1990SE |
| K895017 | Sorba Model CIC-1000, Comp. Impedance CardiographDXG · Traditional | Sorba Medical Systems, Inc. | 03/14/1990SE |
| K897004 | Nova Microsonics Datavue Echo Analysis SystemDXG · Traditional | Advanced Technology Laboratories, Inc. | 03/13/1990SE |
| K896528 | Sfa ModuleDXG · Traditional | Life Sciences Manufacturing, Inc. | 01/26/1990SE |
| K894234 | Sensocor TM R-Test 24OXLDXG · Traditional | Sensocor | 08/03/1989SE |
| K893392 | CPM-1 System Oximeter/Cardiac Output ComputerDXG · Traditional | Baxter Healthcare Corp | 06/20/1989SE |
| K884122 | Type 9320 Cardiac Output System AthenaDXG · Traditional | S & W Medico Teknik | 04/25/1989SE |
| K884619 | Pach-Pen CalculatorDXG · Traditional | Oculab, Inc. | 02/02/1989SE |
| K883855 | Predictor II Signal Averaging ECGDXG · Traditional | Corazonix Corp. | 11/03/1988SE |
| K880301 | 3000 Physiological MonitorDXG · Traditional | Datascope Corp. | 08/19/1988SE |
| K880258 | Witt Biomedical VX-80DXG · Traditional | Witt Biomedical Corporation | 06/16/1988SE |
| K880696 | MX1002 Cable-Cal TMDXG · Traditional | Medex, Inc. | 06/15/1988SE |
| K875167 | Horizon 9000DXG · Traditional | Mennen Medical, Inc. | 05/31/1988SE |
| K872529 | Thermodilution Cardiac Output Computer, Mod. COM-2DXG · Traditional | American Edwards Laboratories | 09/15/1987SE |
| K870375 | Model 617 Cardiac Output ComputerDXG · Traditional | Omnimed B.V. | 06/16/1987SE |
| K871659 | IMS-2000S Stress MonitorDXG · Traditional | Integrated Medical Systems, Inc. | 05/28/1987SE |
| K870934 | IMS-2000R Resting Electrocardiographic SystemDXG · Traditional | Integrated Medical Systems, Inc. | 05/06/1987SE |
| K865101 | Spectramed Model SP1455 HEMOPRO2 SystemDXG · Traditional | Spectramed, Inc. | 04/20/1987SE |
| K861505 | Hipec Analyzer - Ha 100 Hi-Pro Multi-Ecg AnalyzerDXG · Traditional | American Medical Equipment, Inc. | 04/10/1987SE |
| K861543 | Cardiomax-IiDXG · Traditional | Columbus Instruments Intl. Corp. | 03/10/1987SE |
| K862808 | Bioma 2000DXG · Traditional | E.B.S., Inc. | 02/19/1987SE |
| K862261 | Kontron Supermon Cardiac Output Module 7263DXG · Traditional | Kontron Instruments, Inc. | 02/19/1987SE |
| K854371 | MTC 6210A Cardiac Output ComputerDXG · Traditional | Nihon Kohden America, Inc. | 02/19/1987SE |
| K863153 | Modification of Cardiointegram/CardiointegraphDXG · Traditional | Ocg Technology, Inc. | 01/06/1987SE |
| K863308 | 2200I Physiological MonitorDXG · Traditional | Datascope Corp. | 01/02/1987SE |
| K863231 | D100 Computer Cardiac Analysis SystemDXG · Traditional | Dextra Medical, Inc. | 11/25/1986SE |
| K863230 | D200 Advanced Computer Cardiac Analysis SystemDXG · Traditional | Dextra Medical, Inc. | 11/25/1986SE |
| K861092 | Model SP1465 Cardiac Output ComputerDXG · Traditional | Gould, Inc. | 08/18/1986SE |
| K861437 | Qmed System 2150DXG · Traditional | Qmed, Inc. | 05/20/1986SE |
| K860015 | Modified Cherne Cad DetectorDXG · Traditional | Cherne Industries, Inc. | 04/23/1986SE |
| K853018 | Model 3000 Opticath ComputerDXG · Traditional | Oximetrix, Inc. | 01/13/1986SE |
| K854136 | Arrhythmia Review StationDXG · Traditional | Marquette Electronics, Inc. | 12/04/1985SE |
| K852900 | Cverne Cad DetectorDXG · Traditional | Cherne Industries, Inc. | 09/25/1985SE |
| K841967 | Deseret Thermodilution Cardiac OutputDXG · Traditional | Parke-Davis Co. | 08/19/1985SE |
| K834059 | Fukuda Denshi EH-11DXG · Traditional | Fukuda Denshi USA, Inc. | 06/21/1985SE |
| K844116 | Critikon Cardiac Output Computer W/HemodynamicDXG · Traditional | Critikon Company, LLC | 05/28/1985SE |
| K850568 | Model 78231D Cardiac Output ModuleDXG · Traditional | Hewlett-Packard Co. | 04/09/1985SE |
| K844997 | Iai Program-Computer ProgramDXG · Traditional | Intl. Acoustics, Inc. | 04/09/1985SE |
| K844682 | Elecath Cardiac Output ComputerDXG · Traditional | Electro-Catheter Corp. | 03/06/1985SE |
| K844277 | Omikron Pacemaker 837 Unipolar & 838 BipolarDXG · Traditional | Omikron Scientific, Ltd. | 02/15/1985SE |
| K844665 | ComputerDXG · Traditional | Burdick Corp. | 02/13/1985SE |
| K843555 | Cardiac Computer SP1445DXG · Traditional | Gould, Inc. | 02/01/1985SE |
| K842105 | Right Ventricular Ejection Fraction-DXG · Traditional | American Edwards Laboratories | 01/15/1985SE |
| K841401 | SAT-1 Oximeter/Cardiac Output ComputerDXG · Traditional | American Edwards Laboratories | 01/14/1985SE |
| K842706 | ScataidDXG · Traditional | Sc Applied Technology, Inc. | 11/27/1984SE |
| K844022 | Elecath Ventricular Pacing Thermal Dilution CathDXG · Traditional | Electro-Catheter Corp. | 11/20/1984SE |
| K840439 | Recomed Cardiac Output Meter 236067-DXG · Traditional | Litton Medical Electronics | 11/20/1984SE |
| K841256 | Models 78551A 78552ADXG · Traditional | Hewlett-Packard Co. | 10/02/1984SE |
| K842831 | Baim Coronary Sinus Flow CalculatorDXG · Traditional | Electro-Catheter Corp. | 08/27/1984SE |
| K834408 | TX-2 Thermal Dilution Cardiac OutputDXG · Traditional | Waters Instruments, Inc. | 08/23/1984SE |
| K840009 | Nova 12 Cardiac Output ComputerDXG · Traditional | Nova Medical Specialties | 08/22/1984SE |
| K841261 | Computer, Central Processing UnitDXG · Traditional | Nem Computer Corp. | 08/10/1984SE |
| K833756 | System 5000DXG · Traditional | Medical Graphics Corp. | 04/24/1984SE |
| K833914 | Cardiac Output Signal AcquistionDXG · Traditional | Hewlett-Packard Co. | 03/22/1984SE |
| K833913 | Hemodynamic Plug-In Module 78551ADXG · Traditional | Hewlett-Packard Co. | 03/22/1984SE |
| K832644 | Alpha Cardiac Output Cardule #1899DXG · Traditional | Spacelabs, Inc. | 01/27/1984SE |
| K833395 | Sentinel SystemsDXG · Traditional | Quantitative Medicine, Inc. | 01/10/1984SE |
| K831967 | Critikon Cardiac Output ComputerDXG · Traditional | Critikon Company, LLC | 10/28/1983SE |
| K831057 | Video-Dilution Tech. Mark I InstrumentDXG · Traditional | Angio Tec Corp. | 10/19/1983SE |
| K831407 | Cardiac Output ComputerDXG · Traditional | Ziehm International, Inc. | 10/14/1983SE |
| K830892 | Thermodilution Cardiac Output Computer-DXG · Traditional | American Edwards Laboratories | 06/15/1983SE |
| K830628 | Real-Time Spectrum AnalyzerDXG · Traditional | Diagnostic Electronics Corp. | 06/02/1983SE |
| K830003 | Micro Fitness ComputerDXG · Traditional | Microfit, Inc. | 03/10/1983SE |
| K822972 | Il 801 Thermaldilution Cardiac OutputDXG · Traditional | Instrumentation Laboratory CO | 11/01/1982SE |
| K822903 | AutoechoDXG · Traditional | Oxford Medilog, Inc. | 11/01/1982SE |
| K822877 | Model 78554A Data Mgmt. Plug-In ModuleDXG · Traditional | Hewlett-Packard Co. | 10/18/1982SE |
| K822093 | Stat-ScanDXG · Traditional | Survival Technology, Inc. | 09/21/1982SE |
| K820194 | Cardiac Catherization Lab MicroprocessDXG · Traditional | Compu-Cath Corp. | 05/25/1982SE |
| K820820 | Cardio Revue CenterDXG · Traditional | Diasonics, Inc. | 04/29/1982SE |
| K820898 | Vasculab Spectrum Analyzer #SP25DXG · Traditional | Medasonics, Inc. | 04/21/1982SE |
| K813223 | Disposable Plastic Syringe W/NeedleDXG · Traditional | Sam Joo Industrial Co., Ltd. | 04/15/1982SE |
| K813222 | Model 4200 Ellestad Stress Test AnalyzerDXG · Traditional | Del Mar Avionics | 12/29/1981SE |
| K812971 | CardiointegramDXG · Traditional | Ocg Technology, Inc. | 12/29/1981SE |
| K813020 | Bomed-NccomDXG · Traditional | Bomed Medical Mfr., Ltd. | 12/14/1981SE |
| K812932 | Aneriod GauzeDXG · Traditional | Abco Dealers, Inc. | 12/02/1981SE |
| K812638 | Diagnostic Medical ComputerDXG · Traditional | Diagnostic Resources, Inc. | 11/16/1981SE |
| K812757 | Sorenson Thermodilution Cardiac ComputDXG · Traditional | Sorensen Research | 11/02/1981SE |
| K812515 | Cardiac Review StationDXG · Traditional | Diasonics, Inc. | 10/02/1981SE |
| K811560 | Automated Physiologic Profile MonitorDXG · Traditional | Life Sciences Manufacturing, Inc. | 06/18/1981SE |
| K811414 | Baim Coronary Sinus Flow AnalyzerDXG · Traditional | Electro-Catheter Corp. | 06/12/1981SE |
| K811062 | Campbridge ComputraceDXG · Traditional | Cambridge Instruments, Inc. | 05/29/1981SE |
| K810851 | Spectrum Analyzer 8000DXG · Traditional | Radionics Medical, Inc. | 04/23/1981SE |
| K810163 | Am 420 MicroprocessorDXG · Traditional | Honeywell, Inc. | 03/05/1981SE |
| K810177 | Patient Monitor Model CM130, 140DXG · Traditional | Honeywell, Inc. | 02/25/1981SE |
| K810170 | Trend Graph Function BlockDXG · Traditional | Honeywell, Inc. | 02/25/1981SE |
| K802316 | PDS Thermal Dilution Cardiac Module(Out)DXG · Traditional | General Electric Co. | 11/26/1980SE |
| K802800 | Narco Air-Sheilds Sys. 100 Monitor SysDXG · Traditional | Narco Air-Shields | 11/24/1980SE |
| K802476 | Cardiacindex Computer Model SP 1435DXG · Traditional | Gould, Inc. | 11/19/1980SE |
| K802305 | MLC-4200 Cardiac Output ComputerDXG · Traditional | Nihon Kohden America, Inc. | 10/10/1980SE |
| K802198 | Biometric Systolic Time Interval SystemDXG · Traditional | Biometric Analysis Group, Inc. | 09/26/1980SE |
| K792678 | Cardiac Output Computer, M-MLC-4100DXG · Traditional | Nihon Kohden America, Inc. | 01/09/1980SE |
| K792080 | Model 656 Arrhythmia AnalyzerDXG · Traditional | Del Mar Avionics | 12/04/1979SE |
| K791756 | VDCDXG · Traditional | Life Sciences Manufacturing, Inc. | 11/27/1979SE |
| K791753 | Ipag Micronova Interface #781111DXG · Traditional | Robinton Corp. | 10/02/1979SE |
| K790288 | Storage, Digital DSC-1, Control UnitDXG · Traditional | Oxford Medilog, Inc. | 02/27/1979SE |
| K790047 | Cardiac Output Computer, Mdel 9520ADXG · Traditional | Edwards Laboratories | 02/26/1979SE |
| K781805 | Cardiac Computers, CO-10 & CO-10RDXG · Traditional | Waters Assoc., Inc. | 01/29/1979SE |
| K781855 | LVV OptionDXG · Traditional | Honeywell, Inc. | 01/05/1979SE |
| K781535 | Ac Adapter:Models 9525,9526,9527DXG · Traditional | Edwards Laboratories | 09/15/1978SE |
| K772152 | Central Monitoring SystemDXG · Traditional | Burdick Corp. | 11/28/1977SE |
| K771924 | HeartbeaterDXG · Traditional | Dunn Instruments, Inc. | 11/28/1977SE |
| K772158 | Light-Pen System for Quanti. Analy.DXG · Traditional | Varian Assoc., Inc. | 11/22/1977SE |
| K771991 | Cardiac Output Thermodilution ModuleDXG · Traditional | Abbott Laboratories | 11/03/1977SE |
| K771666 | Sphygmomanometer #1235DXG · Traditional | Sears, Roebuck & Co. | 09/30/1977SE |
| K771718 | CARDIOTHERM-500XDXG · Traditional | Columbus Instruments Intl. Corp. | 09/28/1977SE |
| K770675 | Computer, Cardiac Output, Model KM275DXG · Traditional | Lexington Instruments | 04/26/1977SE |
| K770179 | Cardiac Catheterization Lab Monitor SysDXG · Traditional | General Electric Co. | 04/05/1977SE |
| K770330 | Monitor, Pulse Wave Velocity P607DXG · Traditional | Cyborg Corp. | 02/24/1977SE |
| K761166 | TC-1 Cardiac Output ComputerDXG · Traditional | Waters Assoc., Inc. | 12/09/1976SE |
| K760844 | Cardiac Output Computer (Model COC-100)DXG · Traditional | B-D Electrodyne | 11/12/1976SE |
| K760756 | Battery Operated Flow Rate ComputerDXG · Traditional | 3M Health Care, Sarns | 10/15/1976SE |
| K760600 | Cardiac Output ComputerDXG · Traditional | Cardiopulmonary Instrumentation | 10/15/1976SE |
| K760774 | Time-Sharing Multiplexer (Model 78308A)DXG · Traditional | Hewlett-Packard Co. | 10/13/1976SE |
| K760532 | Computer, Cardiac Output (#SP1425)DXG · Traditional | Gould, Inc. | 09/09/1976SE |
| K760192 | Computer, Thermodilution Cardiac (9520)DXG · Traditional | Edwards Laboratories | 07/19/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0756-2021 Class II | CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage:…The expiration date on labeling is incorrect. | Lidco Ltd | 11/19/2020Terminated |
| Z-0859-2021 Class II | icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients…Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values… | ICU Medical, Inc. | 11/09/2020Terminated |
| Z-1927-2020 Class II | The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF…Firm identified software issues which leads to the patient ID and patient information not being stored in… | ICU Medical, Inc. | 02/14/2020Terminated |
| Z-2077-2019 Class II | PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The…The monitor displays an error message . The error message states "internal error restart or service". | Getinge US Sales LLC | 06/05/2019Terminated |
| Z-1147-2013 Class II | HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit…Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. | Transonic Systems Inc | 03/28/2013Terminated |
| Z-0160-2011 | Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences…The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will… | Edwards Lifesciences, Llc | 06/25/2010Terminated |
| Z-0147-2010 | Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03…Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock… | Hospira Inc | 08/11/2009Terminated |
| Z-0146-2010 | Power cord for Q2Plus/Continuous Cardiac Output (CCO)/SO2 Computer, list #s 56711-04-01…Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock… | Hospira Inc | 08/11/2009Terminated |
| Z-0145-2010 | Power cord for Q2 Continuous Cardiac Output (CCO)/SO2 Computer, list #s 52235-04-01…Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock… | Hospira Inc | 08/11/2009Terminated |
| Z-0144-2010 | Power cord for Oximetrix 3 SO2/CO Cardiac Output Computer, list # 50130-04-07, AC cord…Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock… | Hospira Inc | 08/11/2009Terminated |
| Z-0143-2010 | Power cord for Optional Thermal Printer (For use with Model 3300 COC), Oximetrix 3…Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock… | Hospira Inc | 08/11/2009Terminated |
| Z-0142-2010 | Power cord for Model 3300 Cardiac Output Computer, List # 41245-04-03, AC cord…Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock… | Hospira Inc | 08/11/2009Terminated |
| Z-0942-2012 | Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62…Edwards Lifesciences has made the decision to initiate a field corrective action for the Edwards Vigilance… | Edwards Lifesciences, Llc | 09/12/2008Terminated |
| Z-0262-2008 | Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV)…MAP offset errors: If users are "slaving" mean arterial pressure (MAP) from the bedside monitor into the… | Edwards Lifesciences, Llc | 05/17/2007Terminated |