Detector And Alarm, Arrhythmia
FDA product code DSI · Class II (moderate risk) · 21 CFR 870.1025 · Cardiovascular
398510(k) clearances
0PMA approvals
75recalls
Manufacturers
- Siemens Medical Solutions USA, Inc. 27
- Hewlett-Packard Co. 22
- Fukuda Denshi USA, Inc. 19
- Nihon Kohden America, Inc. 18
- Oxford Medilog, Inc. 14
- Mennen Medical, Inc. 13
- Spacelabs Medical, Inc. 13
- Marquette Electronics, Inc. 11
- Spacelabs, Inc. 11
- Del Mar Avionics 10
- Agilent Technologies, Inc. 9
- Medicomp, Inc. 7
- Quinton, Inc. 7
- Medtronic, Inc. 6
- Philips Medical Systems 5
- General Electric Medical Systems Information Techn 5
- Brentwood Instruments, Inc. 5
- Medicalgorithmics S.A. 5
- Card Guard Scientific Survival , Ltd. 5
- Accucore, Inc. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional | Boston Scientific Cardiac Diagnostic… | 01/23/2026SE |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional | Infobionic, Inc. | 07/29/2025SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | iRhythm Technologies, Inc. | 10/30/2024SE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special | Medicalgorithmics S.A. | 04/09/2020SE |
| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation SystemDSI · Abbreviated | Medicalgorithmics S.A. | 07/11/2018SE |
| K173170 | Epicardia AnywhereDSI · Special | Medicomp, Inc. | 01/10/2018SE |
| K153473 | Braemar Telemetry Patch SystemDSI · Special | Braemar Manufacturing, LLC | 07/22/2016SE |
| K153477 | EMMa Electronic Monitoring ManagementDSI · Traditional | Vitasystems GmbH | 05/25/2016SE |
| K152701 | Matrix Mini ECG MonitorDSI · Abbreviated | Global Instrumentation, LLC | 04/22/2016SE |
| K152305 | Nihon Kohden Afib Detection Program QP-039PDSI · Abbreviated | Nihon Kohden Corporation | 04/08/2016SE |
| K151835 | Vital Signs Patch SystemDSI · Special | Lifewatch Technologies , Ltd. | 02/05/2016SE |
| K151269 | ECG Mini System Continuous ECG Monitor and Arrhythmia DetectorDSI · Traditional | Lifewatch Technologies , Ltd. | 01/15/2016SE |
| K152491 | MoMe Software PlatformDSI · Traditional | Infobionic, Inc. | 12/17/2015SE |
| K152550 | Medicalgorithmics Unified Arrhythmia Diagnosic SystemDSI · Special | Medicalgorithmics S.A. | 10/08/2015SE |
| K151188 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice | 09/17/2015SE |
| K143359 | CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorDSI · Traditional | Lifewatch Technologies , Ltd. | 09/11/2015SE |
| K151681 | IntelliVue Patient MonitorDSI · Special | Philips Medizin Systeme Boeblingen GmbH | 07/17/2015SE |
| K150117 | Medtronic Patient AsistantDSI · Traditional | Medtronic, Inc. | 05/27/2015SE |
| K150310 | IntelliVue Patient MonitorDSI · Special | Philips Medizin Systeme Boeblingen GmbH | 05/13/2015SE |
| K142352 | CardiacLinxDSI · Traditional | Ross Medical Technology, Inc. | 03/12/2015SE |
| K141441 | Menntor X7DSI · Traditional | Mennen Medical , Ltd. | 01/09/2015SE |
| K132407 | Vital Signs Patch System (in Short VSP)DSI · Traditional | Lifewatch Technologies , Ltd. | 12/19/2014SE |
| K142180 | TelesenseDSI · Traditional | Scottcare Corporation | 12/12/2014SE |
| K140548 | Corcam Heart MonitorDSI · Traditional | Corcam Technologia, SA | 05/23/2014SE |
| K131000 | V-Patch SystemDSI · Traditional | Intelesens Limited | 01/08/2014SE |
| K124060 | Medical Gorithmics Unified Arrhythmia Diagnostic SystemDSI · Abbreviated | Medicalgorithmics S.A. | 02/21/2013SE |
| K121197 | Bodyguardian System Bodyguardian Control Unit Bodyguardian ConnectDSI · Traditional | Preventice, Inc. | 08/10/2012SE |
| K112921 | Medicalgorithmics Unified Arrhythmia Diagnostic SystemDSI · Abbreviated | Medicalgorithmics S.A. | 05/16/2012SE |
| K120774 | Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT…DSI · Special | Welch Allyn, Inc. | 04/10/2012SE |
| K113125 | Intellivue MX40 Patient MonitorDSI · Special | Philips Medical Systems | 11/17/2011SE |
| K111160 | Intricon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (Apets)DSI · Traditional | Intricon Datrix Corporation | 08/01/2011SE |
| K102507 | Area-Ct, TZ Medical Mcot ECG Monitor and Arrhythmia DetectorDSI · Abbreviated | Tz Medical, Inc. | 06/13/2011SE |
| K103764 | Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…DSI · Traditional | Medtronic, Inc. | 05/04/2011SE |
| K110499 | CG-5108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorDSI · Special | Card Guard Scientific Survival , Ltd. | 04/06/2011SE |
| K103142 | Spacelabs Multi-Parameter ModuleDSI · Special | Spacelabs Healthcare, Inc. | 03/03/2011SE |
| K102111 | Medical Magnetic Tape RecorderDSI · Traditional | Wpr Medical AS | 12/07/2010SE |
| K101703 | Modification to: CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector, Model…DSI · Special | Card Guard Scientific Survival , Ltd. | 07/13/2010SE |
| K101639 | CG-6108 Act-Il Continuous ECG Monitor and Arrythmia DetectorDSI · Special | Card Guard Scientific Survival , Ltd. | 06/25/2010SE |
| K093766 | Vitalogik 6000/6500DSI · Special | Mennen Medical , Ltd. | 05/07/2010SE |
| K100155 | Truvue Wireless Ambulatory ECG Monitoring SystemDSI · Abbreviated | Biomedical Systems Corp. | 04/20/2010SE |
| K092947 | Telesentry, Model TS01DSI · Traditional | Scottcare Corporation | 02/26/2010SE |
| K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90DSI · Traditional | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 11/03/2009SE |
| K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemDSI · Special | Corventis, Inc. | 08/27/2009SE |
| K090037 | Medicalgorithmics Real-Time ECG Monitor and Arrhythmia Detector, Model PocketecgDSI · Abbreviated | Medicalgorithmics SP Z.O.O. | 05/22/2009SE |
| K090834 | Epicardia 5000DSI · Special | Medicomp, Inc. | 05/15/2009SE |
| K083287 | Avivo Mobile Patient Management SystemDSI · Abbreviated | Corventis, Inc. | 02/03/2009SE |
| K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…DSI · Special | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 01/16/2009SE |
| K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…DSI · Traditional | Medtronic, Inc. | 11/07/2008SE |
| K082633 | Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…DSI · Special | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 10/03/2008SE |
| K081444 | Braemar Fusion Wireless - Ambulatory ECG Arrhythmia Monitoring SystemDSI · Traditional | Braemar, Inc. | 07/31/2008SE |
| K081257 | CG-6108 ACT-3L Continuous ECG Monitor & Arrhythmia DetectorDSI · Special | Card Guard Scientific Survival , Ltd. | 05/29/2008SE |
| K071889 | Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A SoftwareDSI · Special | GE Healthcare | 05/19/2008SE |
| K071995 | CG-6108 Continuous ECG Monitor and Arrhythmia DetectorDSI · Traditional | Card Guard Scientific Survival , Ltd. | 12/18/2007SE |
| K073140 | Vitalogik Model 4000/4500DSI · Special | Mennen Medical , Ltd. | 11/21/2007SE |
| K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model(S) 9528,9538DSI · Traditional | Medtronic, Inc. | 11/21/2007SE |
| K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)DSI · Traditional | Medtronic, Inc. | 11/21/2007SE |
| K071805 | Netguard Automated Clinician Alert System, Model 0998-00-1600-XXDSI · Abbreviated | Datascope Corp. | 09/25/2007SE |
| K062976 | Modification to Cic Pro Clinical Information CenterDSI · Special | Ge Medical Systems Information Technologies | 03/16/2007SE |
| K070260 | Star ST and Arrhythmia Software, Release H.0DSI · Special | Philips Medical Systems | 02/23/2007SE |
| K053263 | Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model CN1003DSI · Abbreviated | Cardionet, Inc. | 04/25/2006SE |
| K052288 | VitalogikDSI · Special | Mennen Medical , Ltd. | 12/20/2005SE |
| K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)DSI · Abbreviated | Welch Allyn, Inc. | 12/16/2005SE |
| K050919 | Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…DSI · Abbreviated | Analogic Corp. | 06/14/2005SE |
| K050605 | Spacelabs Medical Multiparameter Module 91496DSI · Special | Spacelabs Medical, Inc. | 05/03/2005SE |
| K050175 | Spacelabs Medical Multiparameter Module 91496DSI · Special | Spacelabs Medical, Inc. | 03/04/2005SE |
| K024213 | Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910…DSI · Traditional | Siemens Medical Solutions USA, Inc. | 03/23/2004SE |
| K033305 | Infinity Multiview Infinity Telemetry SystemDSI · Special | Draeger Medical Systems, Inc. | 10/31/2003SE |
| K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,AND MP90 Patient Monitors, Release B.O.DSI · Special | Philips Medizin Systeme Boblingen GmbH | 10/10/2003SE |
| K031433 | Siemens Infinity Modular Monitors, Models SC 7000, SC 9000XL and SC 8000 with VF3…DSI · Special | Siemens Medical Solutions USA, Inc. | 08/19/2003SE |
| K032370 | Cic Pro Clinical Information Center Central StationDSI · Special | Ge Medical Systems Information Technologies | 08/13/2003SE |
| K023798 | Modification to Envoy Patient MonitorDSI · Special | Mennen Medical , Ltd. | 12/03/2002SE |
| K020550 | Passport 2 with View 12 ECG Analysis Module Model # 0998-00-0170-XXXXDSI · Traditional | Datascope Corp. | 08/28/2002SE |
| K022453 | Modification to Acuity Central Monitoring SystemDSI · Special | Welch Allyn Protocol, Inc. | 08/21/2002SE |
| K013046 | Cosmos SystemDSI · Traditional | Spacelabs Medical, Inc. | 08/21/2002SE |
| K021376 | Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A SoftwareDSI · Traditional | Datex-Ohmeda | 07/24/2002SE |
| K021097 | Quest Exercise Stress System (Quest), Version 3.52DSI · Traditional | Spacelabs Medical, Inc. | 06/28/2002SE |
| K021300 | Modification of Philips Component Compact Monitor, Release A.03, Model M1275BDSI · Special | Philips Medical Systems | 05/08/2002SE |
| K021251 | St/Ar ST and Arrhythmia Software, Release E.I.DSI · Special | Philips Medical Systems | 05/07/2002SE |
| K012467 | Solar 8000M SystemDSI · Traditional | General Electric Medical Systems Information Techn | 02/11/2002SE |
| K002604 | Centurion 2000 Central Station Arrhythmia Patient Monitoring SystemDSI · Traditional | Invivo Research, Inc. | 02/07/2002SE |
| K020084 | Fukuda Denshi Dynascope Model DS-5700DSI · Special | Fukuda Denshi USA, Inc. | 02/06/2002SE |
| K012241 | Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model CN1001DSI · Traditional | Cardionet, Inc. | 02/01/2002SE |
| K014159 | Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient MonitorDSI · Special | Philips Medical Systems, Inc. | 01/18/2002SE |
| K012336 | Modification To:Escort Vision Central Station Telemetry System, Model 20500DSI · Special | Medical Data Electronics | 10/03/2001SE |
| K011339 | Quest Exercise Stress System, Model Configuration 14DSI · Traditional | Spacelabs Burdick, Inc. | 08/20/2001SE |
| K012461 | Siemens Infinity Mib II Duo Protocol ConverterDSI · Special | Siemens Medical Solutions USA, Inc. | 08/17/2001SE |
| K011784 | Modification to Envoy Patient MonitorDSI · Special | Mennen Medical , Ltd. | 08/16/2001SE |
| K011824 | Agilent M2636B Telemon B Monitor (Telemon B)DSI · Special | Agilent Technologies, Inc. | 07/02/2001SE |
| K001120 | Envoy Patient MonitorDSI · Traditional | Mennen Medical , Ltd. | 05/08/2001SE |
| K002758 | Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive…DSI · Traditional | Agilent Technologies Deutschland GmbH | 02/22/2001SE |
| K002068 | ORG-9200ADSI · Traditional | Nihon Kohden America, Inc. | 02/08/2001SE |
| K003576 | Q-Tel RMS (Rehabilitation Management System), Model 000503DSI · Abbreviated | Quinton, Inc. | 01/25/2001SE |
| K003246 | Siemens Multi View Workstation with Vent Viewer OptionDSI · Special | Siemens Medical Solutions USA, Inc. | 12/21/2000SE |
| K003179 | Siemens Multiview Infinity Telemetry SystemDSI · Special | Siemens Medical Solutions USA, Inc. | 11/09/2000SE |
| K001359 | Dash 3000/4000 Patient MonitorDSI · Traditional | General Electric Medical Systems Information Techn | 07/18/2000SE |
| K001436 | Agilent M2636A Telemon MonitorDSI · Special | Agilent Technologies, Inc. | 06/07/2000SE |
| K000779 | Apexpro Telemetry SystemDSI · Traditional | General Electric Medical Systems Information Techn | 05/18/2000SE |
| K001333 | Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact…DSI · Special | Agilent Technologies Deutschland GmbH | 05/17/2000SE |
| K001057 | Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4 Compact…DSI · Special | Agilent Technologies, Inc. | 05/03/2000SE |
| K000746 | Fukuda Denshi Dynascope, Model DS-5800NXDSI · Special | Fukuda Denshi USA, Inc. | 04/07/2000SE |
| K000822 | Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and…DSI · Special | Agilent Technologies, GmbH | 04/06/2000SE |
| K993757 | Solar 7/8000DSI · Traditional | General Electric Medical Systems Information Techn | 03/23/2000SE |
| K992908 | Q-Tel Telemetry System V. 6.0 (ST)DSI · Traditional | Quinton, Inc. | 03/06/2000SE |
| K993383 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A…DSI · Abbreviated | Hewlett-Packard GmbH | 02/03/2000SE |
| K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDSI · Abbreviated | Datascope Corp. | 01/13/2000SE |
| K993516 | HP M2600A Viridia Telemetry SystemDSI · Special | Hewlett-Packard Co. | 11/08/1999SE |
| K992637 | Muse Cardiovascular Information SystemDSI · Traditional | General Electric Medical Systems Information Techn | 11/03/1999SE |
| K993171 | HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154ADSI · Special | Hewlett-Packard Co. | 10/21/1999SE |
| K991773 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…DSI · Special | Hewlett-Packard GmbH | 06/07/1999SE |
| K990093 | Zymed Telemetry System: Model EasiviewDSI · Traditional | Agilent Technologies | 05/11/1999SE |
| K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…DSI · Special | Hewlett-Packard GmbH | 04/19/1999SE |
| K984089 | Zymed Telemetry System, Model Easi ViewDSI · Traditional | Zymed Medical Instrumentation | 02/16/1999SE |
| K990125 | HP Viridia Component Monitoring System, Model Rev. KDSI · Special | Hewlett-Packard GmbH | 01/29/1999SE |
| K981376 | Hewlett-Packard M1205A Viridia 24 CTDSI · Traditional | Hewlett-Packard Co. | 01/04/1999SE |
| K983980 | Siemens Multiview Infinity Telemetry System Enhancement, Additional Arrhythmia CallsDSI · Special | Siemens Medical Solutions USA, Inc. | 11/16/1998SE |
| K980045 | Centurion Central Station Arrhythmia Patient Monitoring SystemDSI · Traditional | Invivo Research, Inc. | 11/16/1998SE |
| K983632 | Siemens SC 8000 Bedside MonitorDSI · Special | Siemens Medical Solutions USA, Inc. | 11/06/1998SE |
| K980186 | Zymed Telemetry SystemDSI · Traditional | Agilent Technologies | 10/07/1998SE |
| K980429 | HP M2600A Viridia Telemetry System (Formerly Known AS the HP 2600A Omni-Care Telemetry…DSI · Traditional | Hewlett-Packard Co. | 09/09/1998SE |
| K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorDSI · Traditional | Siemens Medical Solutions USA, Inc. | 08/24/1998SE |
| K982697 | Modification to Ensemble Central Station MonitorDSI · Special | Mennen Medical, Inc. | 08/12/1998SE |
| K974698 | Siemens SC9000/SC9015 Enhanced with 12-LEAD ST Segment AnalysisDSI · Traditional | Siemens Medical Solutions USA, Inc. | 07/08/1998SE |
| K980728 | Fukuda Denshi Dynascope Model DS-5000 Series Telemetry SystemDSI · Traditional | Fukuda Denshi USA, Inc. | 06/19/1998SE |
| K980882 | Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorDSI · Traditional | Siemens Medical Solutions USA, Inc. | 06/05/1998SE |
| K974792 | CS/3(TM) Monitors*DSI · Traditional | Datex-Engstrom, Inc. | 06/02/1998SE |
| K972502 | Spacelabs Medical Integrated Multiparameter Module 90496DSI · Traditional | Spacelabs Medical, Inc. | 05/28/1998SE |
| K980625 | Siemens Multiview Workstation Enhanced with Diagnostic Statements (Rest ECG)DSI · Traditional | Siemens Medical Solutions USA, Inc. | 05/19/1998SE |
| K974747 | CS/3 Arrhythmia WorkstationDSI · Traditional | Datex-Engstrom, Inc. | 04/23/1998SE |
| K974510 | Envoy Patient MonitorDSI · Traditional | Mennen Medical, Inc. | 04/14/1998SE |
| K971910 | Multi-Parameter Module (M3000A)/DISPLAY Unit (M3046A)DSI · Traditional | Hewlett-Packard GmbH | 03/23/1998SE |
| K972498 | Observer * Central StationDSI · Traditional | Johnson & Johnson Medical, Inc. | 02/17/1998SE |
| K970358 | Ensemble Central Station MonitorDSI · Traditional | Mennen Medical, Inc. | 02/11/1998SE |
| K972714 | Siemens Multiview Workstation Infinity Telemetry SystemDSI · Traditional | Siemens Medical Solutions USA, Inc. | 10/17/1997SE |
| K971131 | Fukuda Denshi Model DS-5100E Portable Patient MonitorDSI · Traditional | Fukuda Denshi USA, Inc. | 10/03/1997SE |
| K972282 | Spacelabs Medical Pcis Patient MonitorsDSI · Traditional | Spacelabs Medical, Inc. | 09/25/1997SE |
| K960884 | Tele Trens TM 10DSI · Traditional | Life Sensing Instrument Company, Inc. | 09/12/1997SE |
| K964624 | Siemens SC9000/SC9015 Bedside Monitoring SystemDSI · Traditional | Siemens Medical Solutions USA, Inc. | 09/11/1997SE |
| K970585 | Fukuda Denshi Dynascope Model DS-5800 Central Station MonitorDSI · Traditional | Fukuda Denshi USA, Inc. | 09/09/1997SE |
| K970348 | Siemens SC/9000/SC9015 Series Surgical Display ControllerDSI · Traditional | Siemens Medical Solutions USA, Inc. | 08/15/1997SE |
| K970920 | Siemens SC9000/SC9015 Bedside Monitoring SystemDSI · Traditional | Siemens Medical Solutions USA, Inc. | 07/29/1997SE |
| K964593 | Diascope Traveller Plus (4053)DSI · Traditional | S & W Medico Teknik A/S | 06/30/1997SE |
| K970012 | Escort Link Central Station MonitorDSI · Traditional | Medical Data Electronics | 06/26/1997SE |
| K965062 | Siemens SC9000/SC9015 Multigas and Multigas+ ModulesDSI · Traditional | Siemens Medical Solutions USA, Inc. | 06/04/1997SE |
| K964832 | Hewlett-Packard Centralvue SoftwareDSI · Traditional | Hewlett-Packard Co. | 05/15/1997SE |
| K970545 | Dash 1000 Patient MonitorDSI · Traditional | Marquette Medical Systems, Inc. | 05/08/1997SE |
| K964187 | Fukada Denshi Dynascope Model DS-5300 Patient MonitorDSI · Traditional | Fukuda Denshi USA, Inc. | 05/01/1997SE |
| K952912 | Spacelabs Medical Integrated Multi-Parameter ModuleDSI · Traditional | Spacelabs Medical, Inc. | 04/02/1997SE |
| K962970 | Spacelabs Medical 12-LEAD Diagnostic ECG Analysis OptionDSI · Traditional | Spacelabs Medical, Inc. | 03/25/1997SE |
| K963057 | Fukuda Denshi Model LX-3240 ECG & Respiratory TransmitterDSI · Traditional | Fukuda Denshi USA, Inc. | 03/21/1997SE |
| K962827 | Alarm Display Unit/Pager-Lan System (Adu)DSI · Traditional | Marquette Electronics, Inc. | 02/24/1997SE |
| K962291 | Siemens SC9000/SC9015 Bedside Monitoring SystemDSI · Traditional | Siemens Medical Solutions USA, Inc. | 01/29/1997SE |
| K955023 | Brentwood Pc-EcgDSI · Traditional | Brentwood Medical Products, Inc. | 01/22/1997SE |
| K962404 | Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring SystemDSI · Traditional | Siemens Medical Solutions USA, Inc. | 01/17/1997SE |
| K964122 | HP Star ST and Arrhhythmia SoftwareDSI · Traditional | Hewlett-Packard Co. | 01/08/1997SE |
| K961165 | HP M2600A Omnicare Telemetry System Model M2600ADSI · Traditional | Hewlett-Packard Co. | 10/10/1996SE |
| K960418 | Eagle Patient MonitorDSI · Traditional | Marquette Electronics, Inc. | 10/02/1996SE |
| K961139 | Eagle Patient Monitor Model 3000/3100DSI · Traditional | Marquette Electronics, Inc. | 08/09/1996SE |
| K955743 | Siemens SC 6000/SC 6000 P Portable Bedside Monitoring SystemDSI · Traditional | Siemens Medical Solutions USA, Inc. | 07/08/1996SE |
| K955059 | Olympus Comm. Ntwk., SC 3000 Wkst. & Remote Display, R 100 RecorderDSI · Traditional | Siemens Medical Solutions USA, Inc. | 06/07/1996SE |
| K952054 | Siemens Sirecust Monitoring (1200, 1200 Neo, 960)DSI · Traditional | Siemens Medical Solutions USA, Inc. | 06/07/1996SE |
| K954852 | Solar 9000 Anesthesia Information MonitorDSI · Traditional | Marquette Electronics, Inc. | 05/29/1996SE |
| K952417 | Quest Exercise Stress SystemDSI · Traditional | Burdick, Inc. | 05/22/1996SE |
| K935732 | Cardio Perfect ST 2001DSI · Traditional | Cardio Control BV | 04/04/1996SE |
| K945944 | Nihon Kohden WEP-8430A Central Telemetry SystemDSI · Traditional | Nihon Kohden America, Inc. | 11/27/1995SE |
| K951370 | Zymed Telemetry System; Model T8010DSI · Traditional | Zymed Medical Instrumentation | 10/06/1995SE |
| K951371 | 1481 T Digital Telemetry System with S-T Segment Analysis OptionDSI · Traditional | Siemens Medical Solutions USA, Inc. | 10/04/1995SE |
| K950821 | HP M1205A Omnicare Component Transport Monitoring System Model 24DSI · Traditional | Hewlett-Packard Co. | 10/03/1995SE |
| K952885 | Single Lead Digital Telemetry TransmitterDSI · Traditional | Spacelabs Medical, Inc. | 09/26/1995SE |
| K945429 | Spacelabs Medical Expansion Module (Model 90352)DSI · Traditional | Spacelabs Medical, Inc. | 08/15/1995SE |
| K942196 | 3050 Diascope NT Patient MonitorDSI · Traditional | S & W Medico Teknik A/S | 06/28/1995SE |
| K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemDSI · Traditional | Siemens Medical Solutions USA, Inc. | 06/27/1995SE |
| K944422 | BSM-8800A Bedside MonitorDSI · Traditional | Nihon Kohden America, Inc. | 05/24/1995SE |
| K935877 | Nihon Kohden Central Nurse Station, CNS-8310A/CNS-8350ADSI · Traditional | Nihon Kohden America, Inc. | 05/24/1995SE |
| K942058 | Spacelabs Medical ECG Module (Model 90492)DSI · Traditional | Spacelabs Medical, Inc. | 05/17/1995SE |
| K945384 | 1481 T Digital Telemetry Systems, EnhancedDSI · Traditional | Siemens Medical Solutions USA, Inc. | 05/10/1995SE |
| K944350 | SC 6000/ SC 6000P/ R50DSI · Traditional | Siemens Medical Solutions USA, Inc. | 04/10/1995SE |
| K933177 | Siemens Sirecust 700 Bedside Monitor ModificationsDSI · Traditional | Siemens Medical Solutions USA, Inc. | 04/10/1995SE |
| K942147 | Pacific Communications Model 1100DSI · Traditional | Accucore, Inc. | 01/30/1995SE |
| K935846 | Model Acuity Central StationDSI · Traditional | Protocol Systems, Inc. | 12/05/1994SE |
| K925510 | Model 90478 & 90479 Telemetry Rec. Module&HousingDSI · Traditional | Spacelabs Medical, Inc. | 10/27/1994SE |
| K920790 | Marquette Eagle MonitorDSI · Traditional | Marquette Electronics, Inc. | 04/19/1994SE |
| K931716 | Battery Pack 1017LADSI · Traditional | Portable Power Systems, Inc. | 02/07/1994SE |
| K930095 | Spacelabs Medical Patient MonitorDSI · Traditional | Spacelabs Medical, Inc. | 09/03/1993SE |
| K923747 | CC Arhythmis Monitoring OptionDSI · Traditional | Hewlett-Packard Co. | 07/20/1993SE |
| K925411 | Model 2041-PC/ST Cardiac Telemetry MonitorDSI · Traditional | Accucore, Inc. | 02/25/1993SE |
| K922027 | Ambulatory (Holter) Recording, ModificationDSI · Traditional | Biosensor Corp. | 02/17/1993SE |
| K920154 | BSM-8800A Bedside MonitorDSI · Traditional | Nihon Kohden America, Inc. | 12/18/1992SE |
| K924672 | Zymed Telemetry Monitor Model T8010 (Preliminary)DSI · Traditional | Agilent Technologies | 12/15/1992SE |
| K920743 | Dual Lead (ECG1 & ECG2) Arrhythmia AnalysisDSI · Traditional | Nihon Kohden America, Inc. | 09/03/1992SE |
| K914092 | BSM-2100A Configured Patient MonitorDSI · Traditional | Nihon Kohden America, Inc. | 05/28/1992SE |
| K913117 | ZB-860PA Multiparameter TransmitterDSI · Traditional | Nihon Kohden America, Inc. | 04/29/1992SE |
| K915153 | Escort-Link Arrhythmia Option 23LDSI · Traditional | Medical Data Electronics | 04/27/1992SE |
| K910929 | Ohmeda Modulus CD Anesthesia System with C.V.DSI · Traditional | Ohmeda Medical | 03/19/1992SE |
| K911835 | Rapsody(Tm) Real-Time Arrhythmia Processing SystemDSI · Traditional | Gs Microsystems | 02/14/1992SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2052-2026 Class II | Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module…Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). | Spacelabs Healthcare, Inc. | 03/26/2026Open, Classified |
| Z-1793-2026 Class II | Multi-parameter Command Module, Model 91496, optioned with Masimo or NellcorMulti-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO)… | Spacelabs Healthcare, Inc. | 02/27/2026Open, Classified |
| Z-0869-2026 Class II | IntelliVue Patient Monitor MX800. Product Number: 865240.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0867-2026 Class II | IntelliVue Patient Monitor MX700. Product Number: 865241.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0866-2026 Class II | IntelliVue Patient Monitor MX600. Product Number: 865242.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0863-2026 Class II | IntelliVue Patient Monitor MX450. Product Number: 866062.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0862-2026 Class II | IntelliVue Patient Monitor MX400. Product Number: 866060.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0861-2026 Class II | IntelliVue Patient Monitor MX100. Product Number: 867033.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0860-2026 Class II | IntelliVue Multi-Measurement Module X3. Product Number: 867030.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0859-2026 Class II | IntelliVue Multi Measurement Server X2. Product Number: M3002A.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0858-2026 Class II | IntelliVue MP90. Product Number: M8010A.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0857-2026 Class II | IntelliVue MP80. Product Number: M8008A.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0856-2026 Class II | IntelliVue MP70. Product Number: M8007A.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0855-2026 Class II | IntelliVue MP60. Product Number: M8005A.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0854-2026 Class II | IntelliVue MP50. Product Number: M8004A.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0853-2026 Class II | IntelliVue MP40. Product Number: M8003A.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0852-2026 Class II | IntelliVue MP30. Product Number: M8002A.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0851-2026 Class II | IntelliVue MP20. Product Number: M8001A.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0850-2026 Class II | IntelliVue MP5. Product Number: M8105A.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-0849-2026 Class II | IntelliVue MP2. Product Number: M8102A.Potential issue where the IntelliVue monitors did not alarm. | Philips North America Llc | 10/31/2025Open, Classified |
| Z-1938-2025 Class II | MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity…The MUSE Administrator Account active directory or local credential could potentially be used from your… | GE Medical Systems Information Technologies… | 04/25/2025Open, Classified |
| Z-0035-2025 Class II | Patient Information Center iX, Product Code 866386, and Patient Information Center iX…During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease… | Philips North America | 04/19/2023Open, Classified |
| Z-1503-2023 Class II | Ultraview SL (UVSL) Command Module, Model 91496Command modules will display the following when parameter processing is suspended, depending on software… | Spacelabs Healthcare, Inc. | 04/12/2023Open, Classified |
| Z-0007-2025 Class II | IntelliVue G7m Anesthesia Gas Module, Product Number 866173The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an… | Philips North America | 01/18/2023Open, Classified |
| Z-0183-2023 Class II | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information…Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed… | iRhythm Technologies, Inc. | 09/28/2022Open, Classified |
| Z-1671-2021 Class II | IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version…Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices | Philips North America Llc | 02/02/2021Terminated |
| Z-0545-2021 Class II | Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for…Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP… | Philips North America Llc | 11/18/2020Terminated |
| Z-0544-2021 Class II | Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage:…Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP… | Philips North America Llc | 11/18/2020Terminated |
| Z-2531-2020 Class II | Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3…Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and… | Philips North America, LLC | 06/08/2020Terminated |
| Z-0727-2020 Class II | CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians…When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of… | GE Healthcare, LLC | 11/12/2019Terminated |
| Z-0726-2020 Class II | CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is…When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of… | GE Healthcare, LLC | 11/12/2019Terminated |
| Z-0725-2020 Class II | ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for…When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of… | GE Healthcare, LLC | 11/12/2019Terminated |
| Z-0175-2020 Class II | ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry…May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center… | GE Healthcare, LLC | 08/30/2019Open, Classified |
| Z-2479-2020 Class II | BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either…The device data being collected and transferred to the monitoring center may not be accurate due to… | Preventice Services, LLC | 08/06/2019Terminated |
| Z-1695-2019 Class II | IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All:…The MX40 may experience increased power consumption and may have a lack of visual and/or audible… | Philips North America, LLC | 03/28/2019Open, Classified |
| Z-1694-2019 Class II | IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All:…The MX40 may experience increased power consumption and may have a lack of visual and/or audible… | Philips North America, LLC | 03/28/2019Open, Classified |
| Z-1693-2019 Class II | IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other…The MX40 may experience increased power consumption and may have a lack of visual and/or audible… | Philips North America, LLC | 03/28/2019Open, Classified |
| Z-1692-2019 Class II | IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and…The MX40 may experience increased power consumption and may have a lack of visual and/or audible… | Philips North America, LLC | 03/28/2019Open, Classified |
| Z-0592-2019 Class II | IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product…A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the… | Philips Electronics North America Corporation | 10/10/2018Open, Classified |
| Z-2144-2018 Class II | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146Five warning statements are missing from the instructions for use. | Philips Electronics North America Corporation | 04/30/2018Terminated |
| Z-2143-2018 Class II | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352Five warning statements are missing from the instructions for use. | Philips Electronics North America Corporation | 04/30/2018Terminated |
| Z-2142-2018 Class II | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351Five warning statements are missing from the instructions for use. | Philips Electronics North America Corporation | 04/30/2018Terminated |
| Z-2141-2018 Class II | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350Five warning statements are missing from the instructions for use. | Philips Electronics North America Corporation | 04/30/2018Terminated |
| Z-1707-2017 Class II | Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part…Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with… | Philips Electronics North America Corporation | 03/06/2017Terminated |
| Z-2343-2016 Class II | 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration…The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming… | Spacelabs Healthcare Inc | 07/01/2016Terminated |
| Z-1315-2016 Class II | TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high…The firm received a complaint of the battery exploding while recharging. | Scottcare Corporation | 02/25/2016Terminated |
| Z-1249-2016 Class II | Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG…Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may… | Medtronic Inc. | 02/23/2016Terminated |
| Z-1577-2015 Class II | Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02.…Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo… | Spacelabs Healthcare Inc | 04/21/2015Terminated |
| Z-1542-2015 Class II | Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option.…Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected.… | Spacelabs Healthcare Inc | 04/17/2015Terminated |
| Z-1705-2014 Class II | Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and…A software anomaly causes temperature alarm limits to change to limits which are not physiologically… | Spacelabs Healthcare Inc | 05/08/2014Terminated |