Electrocardiograph
FDA product code DPS · Class II (moderate risk) · 21 CFR 870.2340 · Cardiovascular
576510(k) clearances
0PMA approvals
53recalls
Manufacturers
- Nihon Kohden America, Inc. 21
- Mortara Instrument, Inc. 21
- Edan Instruments, Inc. 19
- Quinton, Inc. 17
- Hewlett-Packard Co. 15
- Burdick Corp. 12
- Marquette Electronics, Inc. 10
- Ge Medical Systems Information Technologies 9
- Philips Medical Systems 9
- Cambridge Heart, Inc. 8
- Schiller AG 8
- Honeywell, Inc. 7
- Fukuda Denshi USA, Inc. 7
- Birtcher Corp. 6
- Brentwood Instruments, Inc. 6
- Litton Medical Electronics 5
- Suzuken Co., Ltd. 5
- Cambridge Instruments, Inc. 5
- Physio-Control Corp. 5
- Dailycare Biomedical, Inc. 5
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
| K232161 | DeepRhythm PlatformDPS · Traditional | Medicalgorithmics S.A. | 06/20/2024SE |
| K233266 | Mediblu ECG SystemDPS · Traditional | Mediblu Medical, LLC | 06/12/2024SE |
| K232816 | Electrocardiograph, model: ECG301DPS · Traditional | Shenzhen LE Medical Technology Co., Ltd. | 06/07/2024SE |
| K232035 | ImpalaDPS · Traditional | AliveCor, Inc. | 06/07/2024SE |
| K232445 | CSF-4 (CSF-4)DPS · Traditional | Cardiacsense | 05/02/2024SE |
| K232823 | Mcg-S (AM1000)DPS · Traditional | Amcg Co., Ltd. | 04/05/2024SE |
| K231160 | Cardio Q50, Cardio Q70DPS · Traditional | Bionet Co., Ltd. | 12/15/2023SE |
| K230834 | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800HDPS · Traditional | Trismed Co., Ltd. | 11/21/2023SE |
| K232974 | EKGenius Smart SystemDPS · Traditional | Ekgenius, LLC | 11/17/2023SE |
| K232512 | Masimo W1DPS · Traditional | Masimo Corporation | 11/17/2023SE |
| K231150 | Cardio P1DPS · Traditional | Bionet Co., Ltd. | 11/09/2023SE |
| K230812 | Withings Scan Monitor 2.0DPS · Traditional | Withings | 08/23/2023SE |
| K223670 | MESI mTablet ECG Diagnostic System, MESI mTablet ECGDPS · Traditional | Mesi, Development of Medical Devices, Ltd.; Mesi… | 07/28/2023SE |
| K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 ProDPS · Traditional | Edan Instruments, Inc. | 07/28/2023SE |
| K223013 | AccurECG Analysis SystemDPS · Traditional | Accurkardia, Inc. | 06/23/2023SE |
| K221260 | CSF-3DPS · Traditional | Cardiacsense | 01/06/2023SE |
| K221141 | PageWriter TC35 CardiographDPS · Traditional | Medizin Systeme Boblingen GmbH | 12/02/2022SE |
| K220535 | Cardio10DPS · Traditional | Bionet Co., Ltd. | 11/15/2022SE |
| K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 10/18/2022SE |
| K212163 | Coala Heart MonitorDPS · Traditional | Coala Life AB | 04/14/2022SE |
| K212278 | ElectrocardiographDPS · Traditional | Edan Instruments, Inc. | 04/07/2022SE |
| K220362 | LE-12CHDPS · Traditional | Caf Medical Solutions, Inc. | 03/25/2022SE |
| K212112 | Cardiologs Holter PlatformDPS · Traditional | Cardiologs Technologies | 11/18/2021SE |
| K201456 | Scan MonitorDPS · Traditional | Withings SA | 10/05/2021SE |
| K210140 | electrocardiograph: SE-1202DPS · Traditional | Edan Instruments, Inc. | 10/01/2021SE |
| K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50…DPS · Special | Philips Medical Systems | 06/30/2021SE |
| K203786 | MAC 7 - Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 04/30/2021SE |
| K200884 | B-Secur HeartKey Software LibraryDPS · Traditional | B-Secur , Ltd. | 12/07/2020SE |
| K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph…DPS · Traditional | Philips Medical Systems | 09/29/2020SE |
| K193415 | physIQ Heart Rhythm and Respiration ModuleDPS · Traditional | Physiq, Inc. | 06/11/2020SE |
| K200036 | AI-ECG TrackerDPS · Traditional | Shenzhen Carewell Electronics Co., Ltd. | 03/20/2020SE |
| K183425 | Cardiovit AT-102 G2DPS · Traditional | Schiller AG | 03/02/2020SE |
| K191692 | KardioScreenDPS · Traditional | Imedrix Inc. (Formerly Piitech Inc.) | 01/10/2020SE |
| K183322 | physIQ Heart Rhythm and Respiratory ModuleDPS · Traditional | Physiq, Inc. | 07/10/2019SE |
| K182571 | CardioFlux with Faraday Analytical CloudDPS · Traditional | Genetesis, Inc. | 03/15/2019SE |
| K182093 | ZOLL ECG Analysis SoftwareDPS · Traditional | Zoll Manufacturing Corporation | 01/28/2019SE |
| K183369 | COR12 ECGDPS · Traditional | Corscience GmbH & Co. | 12/28/2018SE |
| K182790 | Cardio-TriTest v6.5DPS · Special | Cardio-Phoenix, Inc. | 12/14/2018SE |
| K181998 | CardioBand ECG Event RecorderDPS · Traditional | Samsung Strategy and Innovation Center (Ssic) | 11/15/2018SE |
| K173830 | MAC VU360 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 09/18/2018SE |
| K173952 | Universal SmartECGDPS · Traditional | Vectracor, Inc. | 08/28/2018SE |
| K180234 | physiQ Heart Rhythm ModuleDPS · Traditional | Physiq, Inc. | 08/10/2018SE |
| K172778 | CheckMyHeart PlusDPS · Traditional | Dailycare Biomedical, Inc. | 07/05/2018SE |
| K172068 | Kenz Cardico1211DPS · Traditional | Suzuken Co., Ltd. | 06/01/2018SE |
| K173226 | CardiMax ElectrocardiographDPS · Traditional | Fukuda Denshi USA, Inc. | 04/16/2018SE |
| K180242 | HeRO Symphony, HeRO ES, HeRO solo/duetDPS · Special | Medical Predictive Science Corporation | 02/28/2018SE |
| K162665 | MiCor A100 Wearable ECG RecorderDPS · Traditional | Mitac International Corp. | 01/26/2018SE |
| K171942 | ElectrocardiographDPS · Special | Edan Instruments, Inc. | 01/24/2018SE |
| K171360 | CONTEC ElectrocardiographDPS · Traditional | Contec Medical Systems Co.,Ltd | 01/22/2018SE |
| K171517 | Digital ElectrocardiographDPS · Special | Biocare Bio-Medical Equipment Co., Ltd. | 01/11/2018SE |
| K163607 | ECG Acquisition SystemsDPS · Traditional | Vales & Hills Biomedical Tech. , Ltd. | 12/15/2017SE |
| K170154 | Creavo Vitalscan MagnetocardiographDPS · Traditional | Creavo Medical Technologies, Ltd. | 10/12/2017SE |
| K171943 | ElectrocardiographDPS · Traditional | Edan Instruments, Inc. | 09/25/2017SE |
| K170182 | Cardiovit FT-1DPS · Traditional | Schiller AG | 07/19/2017SE |
| K170568 | CardioLogs ECG Analysis PlatformDPS · Traditional | Cardiologs Technologies | 06/26/2017SE |
| K170995 | ElectrocardiographDPS · Traditional | Edan Instruments, Inc. | 06/02/2017SE |
| K170954 | Portable ECG MonitorDPS · Traditional | Contec Medical Systems Co.,Ltd | 05/30/2017SE |
| K160667 | Anybattery C2 Rechargeable BatteryDPS · Traditional | Anybattery, Inc. | 05/11/2017SE |
| K160876 | PC ECGDPS · Traditional | Edan Instruments, Inc. | 02/15/2017SE |
| K160746 | CARDIOLINE touchECGDPS · Traditional | Cardioline S.P.A | 11/02/2016SE |
| K160840 | ECG100+, ECG200+DPS · Traditional | Cardioline S.P.A | 08/12/2016SE |
| K152135 | Quantitative Electrocardiographic Detector (QED 2000)DPS · Traditional | Acme Portable Machines, Inc. | 08/09/2016SE |
| K161302 | PC ECGDPS · Traditional | Edan Instruments, Inc. | 07/01/2016SE |
| K152863 | Portable ECG MonitorDPS · Traditional | Contec Medical Systems Co.,Ltd | 06/22/2016SE |
| K152043 | Diagnostic Station DS20DPS · Traditional | Schiller AG | 05/06/2016SE |
| K151135 | Model 621/624 BiomagnetometerDPS · Traditional | Tristan Technologies, Inc. | 03/15/2016SE |
| K142969 | ANI MonitorDPS · Traditional | Mdoloris Medical Systems Sas | 02/23/2016SE |
| K160092 | Digital ElectrocardiographDPS · Special | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 02/12/2016SE |
| K152427 | PC ECGDPS · Traditional | Edan Instruments, Inc. | 02/05/2016SE |
| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing SystemsDPS · Traditional | Mortara Instrument, Inc. | 01/06/2016SE |
| K152384 | Digital ElectrocardiographDPS · Traditional | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 12/18/2015SE |
| K150564 | Spaulding Electrocardiograph 2100iQDPS · Traditional | Spaulding Clinical Research, LLC | 08/12/2015SE |
| K143432 | Cardio-TriTestDPS · Traditional | Cardio-Phoenix, Inc. | 06/03/2015SE |
| K143436 | InvisionECG SystemDPS · Traditional | Invisionheart, Inc. | 05/21/2015SE |
| K142551 | QANS (Quantitative Autonomic Nervous System) Monitoring SystemDPS · Traditional | Hhssystems, LLC | 04/16/2015SE |
| K142693 | ZywieAI Software LibraryDPS · Traditional | Zywie, Inc. | 02/20/2015SE |
| K141946 | Digital ElectrocardiographDPS · Traditional | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 02/13/2015SE |
| K133985 | Digital ElectrocardiographDPS · Traditional | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 01/22/2015SE |
| K142288 | MAC 800 Resting ECG Analysis SystemDPS · Special | Ge Medical Systems China Co., Ltd. | 12/03/2014SE |
| K140020 | Hyperq ACS-100 SystemDPS · Traditional | Bsp-Biiological Signal Processing, Ltd. | 10/28/2014SE |
| K142105 | Eli 380 ElectrocardiographDPS · Special | Mortara Instrument, Inc. | 09/05/2014SE |
| K141582 | CP150 Electrocardiograph with Spirometry OptionDPS · Special | Welch Allyn | 07/11/2014SE |
| K131858 | Digital ElectrocardiographDPS · Traditional | Guangdong Biolight Meditech Co., Ltd. | 06/11/2014SE |
| K131900 | Contec ElectrocardiographDPS · Traditional | Contec Medical System Co., Ltd. | 03/05/2014SE |
| K131503 | SE-601 Series ElectrocardiographDPS · Traditional | Edan Instruments, Inc. | 02/25/2014SE |
| K122632 | Guava IIDPS · Traditional | Cardiocomm Solutions, Inc. | 02/11/2014SE |
| K130921 | Alivecor Heart Monitor OTCDPS · Traditional | AliveCor, Inc. | 02/06/2014SE |
| K132758 | Digital ElectrocardiographDPS · Special | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 01/30/2014SE |
| K133622 | Mac 2000 ECG Analysis SystemDPS · Traditional | Wipro GE Healthcare | 01/23/2014SE |
| K131819 | PC ECGDPS · Traditional | Edan Instruments, Inc. | 11/22/2013SE |
| K131262 | Digital ElectrocardiographsDPS · Traditional | Sonoscape Company Limited | 11/14/2013SE |
| K132068 | Philips DXL 12/16-LEAD ECG AlgorithmDPS · Special | Philips Medical Systems | 09/26/2013SE |
| K130409 | Alivecor Heart MonitorDPS · Traditional | AliveCor, Inc. | 09/06/2013SE |
| K130207 | Spacelabs Healthcare CardioexpressDPS · Traditional | Spacelabs Healthcare, Ltd. | 07/23/2013SE |
| K131572 | Micro Ambulatory ECG RecorderDPS · Traditional | Dimetek Digital Medical Technologies, Ltd. | 07/22/2013SE |
| K131573 | CP150 ElectrocardiographDPS · Special | Welch Allyn, Inc. | 07/03/2013SE |
| K121825 | Cs-Mag IIDPS · Traditional | Biomagnetik-Park GmbH | 03/11/2013SE |
| K123816 | Digital ElectrocardiographsDPS · Special | Shenzhen Biocare Electronics Co., Ltd. | 02/27/2013SE |
| K123217 | CardeascreenDPS · Traditional | Cardea Associates, Inc. | 02/05/2013SE |
| K120770 | QT Guard Plus Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies | 12/06/2012SE |
| K122356 | Alivecor Heart Monitor for IphoneDPS · Traditional | AliveCor, Inc. | 11/19/2012SE |
| K122712 | Digital ElectrocardiographDPS · Special | Shenzhen Biocare Electronics Co., Ltd. | 10/25/2012SE |
| K122073 | Eli 280 ElectrocardiographDPS · Special | Mortara Instrument, Inc. | 08/02/2012SE |
| K120865 | Rscribe ElectrocardiographDPS · Special | Mortara Instrument, Inc. | 07/19/2012SE |
| K112622 | Handheld ECG MonitorDPS · Traditional | Beijing Choice Electronic Technololgy Co., Ltd. | 07/19/2012SE |
| K113306 | Cardio 7DPS · Traditional | Bionet Co., Ltd. | 07/16/2012SE |
| K121009 | Heartcheck ECG Pen with Gems HomeDPS · Traditional | Cardiocomm Solutions, Inc. | 05/17/2012SE |
| K113485 | ElectrocardiographDPS · Traditional | Shenzhen Carewell Electronics Co., Ltd. | 04/25/2012SE |
| K113144 | Pagewriter TC 20, 30, 50, 70DPS · Traditional | Philips Medical Systems | 04/03/2012SE |
| K120188 | ElectrocardiographDPS · Special | Edan Instruments, Inc. | 03/16/2012SE |
| K112959 | Calg-Str Exercise ECG Analysis AlgorithmDPS · Traditional | Philips Health Care | 01/26/2012SE |
| K111159 | Heartcheck Pen Handheld ECG with Gems HomeDPS · Traditional | Cardiocomm Solutions, Inc. | 12/22/2011SE |
| K113234 | Mobcardio SystemDPS · Traditional | Mobhealth Incorporation | 11/17/2011SE |
| K102378 | Vectraplexecg System with VectraplexamiDPS · Traditional | Vectracor, Inc. | 11/02/2011SE |
| K103791 | Physioglove Es with ECG AnalysisDPS · Traditional | Commwell , Ltd. | 10/21/2011SE |
| K112431 | Digital ElectrocardiographDPS · Special | Shenzhen Biocare Electronics Co., Ltd. | 09/22/2011SE |
| K111438 | Reka E100DPS · Abbreviated | Reka Pte, Ltd. | 09/12/2011SE |
| K111805 | ECG Series ElectrocardiographDPS · Traditional | Advanced Instrumentations, Inc. | 08/24/2011SE |
| K112135 | ECG-6 Series ElectrocardiographDPS · Traditional | Advanced Instrumentations, Inc. | 08/05/2011SE |
| K110328 | ACG-8511 Portable ECG MonitorDPS · Traditional | Andon Health Co, Ltd. | 07/15/2011SE |
| K103077 | ECG PenDPS · Traditional | Meridian Dynamics Biomedical, Inc. | 07/13/2011SE |
| K111601 | HeroDPS · Special | Medical Predictive Science Corp. | 07/08/2011SE |
| K102767 | Cardio XPDPS · Traditional | Bionet Co., Ltd. | 06/03/2011SE |
| K103765 | Mac 600 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 05/17/2011SE |
| K110266 | Mac 5500 HD, Mac 3500DPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 04/29/2011SE |
| K101867 | Vicor PD2I AnalyzerDPS · Traditional | Vicor Technologies, Inc. | 04/14/2011SE |
| K103427 | Mobileecg SystemDPS · Traditional | Memtec Corp. | 03/24/2011SE |
| K103640 | Midmark IqecgDPS · Traditional | Brentwood Medical Technology Corp. | 03/22/2011SE |
| K110065 | Spaulding Iq ElectrocardiographDPS · Abbreviated | Spaulding Clinical Research, LLC | 03/02/2011SE |
| K101876 | Digital Electrocardiograph, Models ECG-1210, ECG-1230, ECG-3010, ECG-6010DPS · Traditional | Shenzhen Biocare Electronics Co., Ltd. | 03/01/2011SE |
| K101569 | V-Trust Model TD-2202 Portable ECG RecorderDPS · Traditional | Taidoc Technology Corporation | 03/01/2011SE |
| K102206 | Eli 10 Electrocardiograph Model Eli 10DPS · Abbreviated | Mortara Instrument, Inc. | 02/18/2011SE |
| K101016 | Ans SystemDPS · Traditional | Caird Technology | 01/28/2011SE |
| K102854 | PC ECGDPS · Special | Edan Instruments, Inc. | 12/03/2010SE |
| K102830 | ElectrocardiographDPS · Special | Edan Instruments, Inc. | 12/02/2010SE |
| K100813 | QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card UsbDPS · Special | Pulse Biomedical, Inc. | 07/23/2010SE |
| K101403 | Eli 250 ElectrocardiographDPS · Abbreviated | Mortara Instrument, Inc. | 07/02/2010SE |
| K101115 | Eli 150 Electrocardiograph Model Eli 150DPS · Abbreviated | Mortara Instrument, Inc. | 06/18/2010SE |
| K093211 | Carecenter MDDPS · Traditional | Cardiac Science Corporation | 06/03/2010SE |
| K100127 | Eli 230 ElectrocardiographDPS · Abbreviated | Mortara Instrument, Inc. | 04/16/2010SE |
| K093869 | SE-601 Series ElectrocardiographDPS · Traditional | Edan Instruments, Inc. | 04/01/2010SE |
| K093872 | Handheld ECG Monitor, Model MD100DPS · Traditional | Beijing Choice Electronic Technololgy Co., Ltd. | 03/31/2010SE |
| K093339 | Eli PC ElectrocardiographDPS · Abbreviated | Mortara Instrument, Inc. | 02/19/2010SE |
| K093172 | Quantitative Electrocardiographic Detector (Qed 1000)DPS · Traditional | Dynacardia, Inc. | 01/20/2010SE |
| K092663 | Eli 350 ElectrocardiographDPS · Abbreviated | Mortara Instrument, Inc. | 12/14/2009SE |
| K092010 | PC ECG, Model SE-1010DPS · Traditional | Edan Instruments, Inc. | 10/22/2009SE |
| K083715 | Beltbeat WF-400DPS · Traditional | Bonus Communicaciones Srl | 09/15/2009SE |
| K092576 | Gem Heart One/One+DPS · Traditional | Gem-Med S.L. | 09/04/2009SE |
| K090936 | Single-Channel Handheld Electrocardiograph, Model ECG80ADPS · Traditional | Contec Medical System Co., Ltd. | 08/25/2009SE |
| K091513 | Smart ECG Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…DPS · Traditional | Edan Instruments, Inc. | 07/24/2009SE |
| K091397 | Ecscope 200DPS · Traditional | Dyansys, Inc. | 07/08/2009SE |
| K090367 | SE-601 Series ElectrocardiographDPS · Traditional | Edan Instruments, Inc. | 06/03/2009SE |
| K091358 | Ecscope 100DPS · Traditional | Dyansys, Inc. | 05/28/2009SE |
| K090249 | Modification to: Micro-Induction 1000 SystemDPS · Special | Harbinger Medical, Inc. | 04/03/2009SE |
| K082967 | Mortara Stress Echo BedDPS · Special | Medical Positioning, Inc. | 03/26/2009SE |
| K090483 | Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series…DPS · Special | Philips Medical Systems | 03/20/2009SE |
| K090212 | Mac 800 Resting ECG Analysis SystemDPS · Special | Ge Medical Syst. Information Technologies | 02/19/2009SE |
| K082124 | Carditte MicrotelDPS · Special | Et Medical Devices Spa | 02/19/2009SE |
| K082946 | Mortara Eli 350 ElectrocardiographDPS · Traditional | Mortara Instrument, Inc. | 12/29/2008SE |
| K082709 | Vicor PD2I Analyzer, Version 2.1DPS · Traditional | Vicor Technologies, Inc. | 12/29/2008SE |
| K082380 | Vicardio 12BDPS · Traditional | Energy-Lab Technologies GmbH | 12/03/2008SE |
| K082013 | Clue Medical and Clue Medical BasicDPS · Traditional | Telovital GmbH Telemedizin | 11/10/2008SE |
| K080933 | Handheld ECG Monitor, Model MD100DPS · Traditional | Beijing Choice Electronic Technololgy Co., Ltd. | 09/26/2008SE |
| K082312 | Prime ECG System (with Enhanced Diagnostic Algorithm)DPS · Traditional | Heartscape Technologies, Ltd. | 09/12/2008SE |
| K082173 | Q-Stress and Heartstride, Models QSTRESS/Q40 and H4/H4SDPS · Special | Cardiac Science Corporation | 08/26/2008SE |
| K081437 | Mac 1600 ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies | 07/15/2008SE |
| K081473 | Hero, Version 2.0DPS · Special | Medical Predictive Science Corp. | 06/27/2008SE |
| K080999 | Pagewriter CardiographDPS · Special | Philips Medical Systems | 05/09/2008SE |
| K080884 | QHRV 1 - Health Assessment SystemDPS · Traditional | Medtechs, LLC | 04/11/2008SE |
| K073625 | Modification to: Mac 5500 Resting ECG Analysis SystemDPS · Special | Ge Healthcare Systems Information Technologies | 01/25/2008SE |
| K080036 | Portable Ecscope 12IDPS · Traditional | Dyansys, Inc. | 01/16/2008SE |
| K072449 | CP100 & 200 12-LEAD Resting ElectrocardiographsDPS · Abbreviated | Welch Allyn, Inc. | 11/29/2007SE |
| K071168 | The Portable AnsiscopeDPS · Traditional | Dyansys, Inc. | 08/31/2007SE |
| K072353 | Portable EcscopeDPS · Traditional | Dyansys Corp | 08/30/2007SE |
| K072217 | ECG-1250A Series Cardiofax S and ECG-1350A Series Cardiofax MDPS · Special | Nihon Kohden America, Inc. | 08/30/2007SE |
| K072060 | QP-156E ECG Exercise Test Option for the ECG-1500A Series/Cardiofax VDPS · Special | Nihon Kohden America, Inc. | 08/17/2007SE |
| K061123 | Palm ECG Recorder, Model EP-201/202DPS · Traditional | Parama-Tech Company., Ltd. | 06/29/2007SE |
| K070614 | CorscreenDPS · Traditional | Viasys Healthcare GmbH | 05/04/2007SE |
| K070136 | Audicor 200 System, Models 200D and 200SDPS · Traditional | Inovise Medical, Inc. | 04/13/2007SE |
| K062282 | Monebo Automated ECG Analysis and Interpretation Software Library, Version 3.0DPS · Traditional | Monebo Technologies, Inc. | 03/22/2007SE |
| K070539 | Mortara Eli 10 ElectrocardiographDPS · Special | Mortara Instrument, Inc. | 03/15/2007SE |
| K062894 | Instantcheck Rtd-Ecg Monitor, Model RMH4.0DPS · Traditional | Dailycare Biomedical, Inc. | 02/08/2007SE |
| K062677 | Eli 350 ElectrocardiographDPS · Special | Mortara Instrument, Inc. | 11/15/2006SE |
| K062469 | Voyager 12DPS · Special | Del Mar Reynolds Medical, Ltd. | 11/03/2006SE |
| K062068 | Intelwave Heart Rate Variability System, Version 1.0DPS · Traditional | Intelwave, LLC | 10/27/2006SE |
| K060766 | Portable, Electrocardiograph (ECG) Monitor, Model HCG-801DPS · Traditional | Omron Healthcare, Inc. | 06/09/2006SE |
| K052511 | Cardiofax Ce, Model ECG-1500 aDPS · Traditional | Nihon Kohden America, Inc. | 05/24/2006SE |
| K050674 | Physioglove EsDPS · Traditional | Commwell , Ltd. | 04/25/2006SE |
| K060167 | Atria 3100, Atria 6100DPS · Abbreviated | Cardiac Science Corporation | 04/19/2006SE |
| K052898 | Iqmark Ez StressDPS · Traditional | Brentwood Medical Technology Corp. | 03/28/2006SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3012-2026 Class II | Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software…A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate… | Midmark Corporation | 07/20/2026Open, Classified |
| Z-2956-2026 Class II | Cardiac Workstation 7000. Product Number: 860441.Device will intermittently provide inaccurate data related to native heart rate. | Philips North America Llc | 07/01/2026Open, Classified |
| Z-2955-2026 Class II | Cardiac Workstation 5000. Product Number: 860439.Device will intermittently provide inaccurate data related to native heart rate. | Philips North America Llc | 07/01/2026Open, Classified |
| Z-2876-2026 Class II | GE Healthcare MAC VU360, REF# part number 2030361-023; ElectrocardiographSoftware issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview… | GE Medical Systems Information Technologies… | 06/29/2026Open, Classified |
| Z-0166-2026 Class II | Cardiac Workstation 7000; Model Number: 860441;Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac… | Philips North America | 09/12/2025Open, Classified |
| Z-0165-2026 Class II | Cardiac Workstation 5000; Model Number: 860439;Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac… | Philips North America | 09/12/2025Open, Classified |
| Z-0231-2026 Class II | MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel…If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in… | GE Medical Systems, LLC | 08/22/2025Open, Classified |
| Z-1560-2025 Class II | Welch Allyn CP150 Electrocardiograph:There were customer reports of devices which experienced battery-related fires. The investigation found that… | Baxter Healthcare Corporation | 03/24/2025Open, Classified |
| Z-0708-2025 Class I | Monitoring Service Application (MSA). Software to process, analyze, display, and report…Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and… | Braemar Manufacturing, LLC | 12/18/2024Open, Classified |
| Z-0325-2025 Class II | Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic…There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system… | Baxter Healthcare Corporation | 10/11/2024Open, Classified |
| Z-0322-2025 Class II | Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; ElectrocardiographThere is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system… | Baxter Healthcare Corporation | 10/11/2024Open, Classified |
| Z-0321-2025 Class II | Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress testThere is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system… | Baxter Healthcare Corporation | 10/11/2024Open, Classified |
| Z-2734-2024 Class II | CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT… | Schiller, Ag | 07/24/2024Open, Classified |
| Z-2323-2024 Class II | Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB.…During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The… | Baxter Healthcare Corporation | 06/03/2024Open, Classified |
| Z-0707-2024 Class II | XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes:…Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF)… | Baxter Healthcare Corporation | 12/08/2023Open, Classified |
| Z-0706-2024 Class II | XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a)…Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF)… | Baxter Healthcare Corporation | 12/08/2023Open, Classified |
| Z-0705-2024 Class II | Q-Stress Cardiac Stress Testing System, version 6, with below product name / product…Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF)… | Baxter Healthcare Corporation | 12/08/2023Open, Classified |
| Z-1280-2023 Class II | Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch…A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the… | Withings | 12/19/2022Open, Classified |
| Z-1013-2023 Class II | Baxter Electrocardiograph, ELI 380 -DCS21One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake… | Baxter Healthcare Corporation | 10/31/2022Terminated |
| Z-0011-2022 Class II | ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and…The devices malfunction under specific operator workflows. | Welch Allyn Inc Mortara | 09/03/2021Open, Classified |
| Z-1485-2021 Class II | AM12M Acquisition Module accessory. Impacted software version of the AM12M is version…Devices do not meet IEC 60601-2-27 requirements as labeled. | Welch Allyn Inc Mortara | 03/31/2021Terminated |
| Z-1484-2021 Class II | Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory.…Devices do not meet IEC 60601-2-27 requirements as labeled. | Welch Allyn Inc Mortara | 03/31/2021Terminated |
| Z-1483-2021 Class II | ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software…Devices do not meet IEC 60601-2-27 requirements as labeled. | Welch Allyn Inc Mortara | 03/31/2021Terminated |
| Z-1482-2021 Class II | ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software…Devices do not meet IEC 60601-2-27 requirements as labeled. | Welch Allyn Inc Mortara | 03/31/2021Terminated |
| Z-0553-2021 Class II | ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance…The radio within the device can become disassociated with the wireless access point. | Welch Allyn, Inc/Mortara | 11/11/2020Terminated |
| Z-0543-2021 Class II | MAC VU360, ElectrocardiographIncorrect patient identification and/or patient demographic errors. | GE Healthcare, LLC | 10/27/2020Terminated |
| Z-2337-2020 Class II | Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1…Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not… | Philips North America, LLC | 05/19/2020Terminated |
| Z-1819-2020 Class II | Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | Welch Allyn, Inc/Mortara | 03/18/2020Terminated |
| Z-1818-2020 Class II | Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | Welch Allyn, Inc/Mortara | 03/18/2020Terminated |
| Z-1817-2020 Class II | Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | Welch Allyn, Inc/Mortara | 03/18/2020Terminated |
| Z-1816-2020 Class II | Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | Welch Allyn, Inc/Mortara | 03/18/2020Terminated |
| Z-1815-2020 Class II | S4 and patient cable for the S4 Wireless Telemeter with the following device names:…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | Welch Allyn, Inc/Mortara | 03/18/2020Terminated |
| Z-1814-2020 Class II | X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | Welch Allyn, Inc/Mortara | 03/18/2020Terminated |
| Z-1813-2020 Class II | T12. Incorporates wireless electrocardiographic technology to achieve the real-time…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | Welch Allyn, Inc/Mortara | 03/18/2020Terminated |
| Z-1812-2020 Class II | H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | Welch Allyn, Inc/Mortara | 03/18/2020Terminated |
| Z-1811-2020 Class II | ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | Welch Allyn, Inc/Mortara | 03/18/2020Terminated |
| Z-1810-2020 Class II | Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350…Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25… | Welch Allyn, Inc/Mortara | 03/18/2020Terminated |
| Z-0861-2019 Class II | PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | Philips North America, LLC | 01/09/2019Open, Classified |
| Z-0860-2019 Class II | PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | Philips North America, LLC | 01/09/2019Open, Classified |
| Z-0859-2019 Class II | PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | Philips North America, LLC | 01/09/2019Open, Classified |
| Z-0858-2019 Class II | PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | Philips North America, LLC | 01/09/2019Open, Classified |
| Z-0857-2019 Class II | PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | Philips North America, LLC | 01/09/2019Open, Classified |
| Z-0856-2019 Class II | PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | Philips North America, LLC | 01/09/2019Open, Classified |
| Z-0855-2019 Class II | PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | Philips North America, LLC | 01/09/2019Open, Classified |
| Z-0854-2019 Class II | PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | Philips North America, LLC | 01/09/2019Open, Classified |
| Z-0853-2019 Class II | PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used…Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to… | Philips North America, LLC | 01/09/2019Open, Classified |
| Z-1796-2015 Class II | ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance…Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380… | Mortara Instrument, Inc | 05/29/2015Terminated |
| Z-2584-2011 | Philips SureSigns VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251…Speakers on the SureSigns Patient Monitors and Vital Signs, failure may be identified by the display of a… | Philips Healthcare Inc. | 06/10/2011Terminated |
| Z-0743-2012 | Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable…CardioExpress SL6 ECG cable provided with the electrocardiograph is mislabeled. The left arm (LA) is… | Del Mar Reynolds Medical, Ltd. | 09/10/2010Terminated |
| Z-0041-2012 | ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601…The 3 leads of the cable, RL, LA and LL were labeled in wrong sequence. The left arm (LA) is mislabeled as… | Edan Instruments, Inc. | 09/10/2010Terminated |