System, Network And Communication, Physiological Monitors
FDA product code MSX · Class II (moderate risk) · 21 CFR 870.2300 · Cardiovascular
120510(k) clearances
0PMA approvals
19recalls
Manufacturers
- Data Critical Corp. 9
- Datex-Ohmeda, Inc. 9
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 7
- Philips Medical Systems 6
- GE Healthcare, LLC 5
- Draeger Medical Systems, Inc. 5
- Current Health , Ltd. 5
- Visicu, Inc. 5
- Earlysense, Ltd. 4
- General Electric Medical Systems Information Techn 3
- Airstrip Technologies, LP 3
- Cardiopulmonary Corp. 3
- Biofourmis Singapore Pte., Ltd. 2
- Spacelabs Medical, Inc. 2
- Ascom Ums Srl Unipersonale 2
- Ge Medical Systems Information Technologies 2
- Physio-Control Corp. 2
- Corsano Health B.V. 2
- Ascom (Sweden) AB 2
- Marquette Electronics, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261287 | Digistat CareMSX · Traditional | Ascom Ums Srl Unipersonale | 09/12/2026SE |
| K260211 | Dashboard (P007000)MSX · Traditional | Hill-Rom, Inc. | 08/13/2026SE |
| K261367 | Corsano CardioWatch 287-2 SystemMSX · Traditional | Corsano Health B.V. | 07/26/2026SE |
| K253654 | IntelliVue Measurement Rack 6000 (867317)MSX · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/30/2026SE |
| K243270 | TigerConnect Alarm ManagementMSX · Traditional | Tigerconnect | 09/30/2025SE |
| K242728 | BeneVision Central Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/31/2025SE |
| K242750 | Central StationMSX · Traditional | Nihon Kohden Digital Health Solutions, LLC | 06/05/2025SE |
| K242842 | ANNE View, Central HubMSX · Traditional | Sibel Health, Inc. | 01/08/2025SE |
| K241397 | HinscopeMSX · Traditional | Hinlab Sas | 11/14/2024SE |
| K233834 | Infinity Gateway SuiteMSX · Traditional | Draeger Medical Systems, Inc. | 07/12/2024SE |
| K233418 | Biofourmis Everion+ (G2)MSX · Traditional | Biofourmis Singapore Pte., Ltd. | 05/09/2024SE |
| K232548 | Corsano CardioWatch 287-2 SystemMSX · Traditional | Corsano Health B.V. | 03/22/2024SE |
| K231506 | Current Health SystemMSX · Special | Current Health , Ltd. | 08/24/2023SE |
| K223567 | CNS-2101 Central MonitorMSX · Traditional | Nihon Kohden Corporation | 07/31/2023SE |
| K213863 | Everion+ SystemMSX · Traditional | Biofourmis Singapore Pte., Ltd. | 02/23/2023SE |
| K222550 | Current Health SystemMSX · Special | Current Health , Ltd. | 11/01/2022SE |
| K203579 | Infinity Gateway SuiteMSX · Traditional | Draeger Medical Systems, Inc. | 06/07/2022SE |
| K211046 | eCareManager 4.5MSX · Traditional | Visicu, Inc. | 06/03/2022SE |
| K220058 | BeneVision Central Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 06/01/2022SE |
| K212622 | Zyter RPMMSX · Traditional | Zyter, Inc. | 02/11/2022SE |
| K211949 | AirStrip ONE Web Client with Alarm Communication Management (ACM)MSX · Special | Airstrip Technologies, Inc. | 12/09/2021SE |
| K210160 | AlertWatch:ACMSX · Traditional | Alertwatch, Inc. | 09/10/2021SE |
| K210133 | Current Health Monitoring System Gen 2 (G2)MSX · Traditional | Current Health | 09/03/2021SE |
| K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring SystemMSX · Traditional | Taiwan Aulisa Medical Devices Technologies, Inc. | 10/30/2020SE |
| K193421 | Smart Alarm InterfaceMSX · Traditional | Boxview, LLC | 10/30/2020SE |
| K192952 | Spire Health Remote Patient Monitoring SystemMSX · Traditional | Spire, Inc. D/B/A Spire Health | 06/05/2020SE |
| K193391 | BeneVision Central Monitoring SystemMSX · Special | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/21/2020SE |
| K193043 | Critical Alert CommonPath EnterpriseMSX · Traditional | Critical Alert | 05/11/2020SE |
| K191272 | Wearable Device, Wearable PackageMSX · Traditional | Current Health , Ltd. | 07/12/2019SE |
| K182637 | Philips IntelliVue XDS SoftwareMSX · Traditional | Philips Medizin Systeme Boeblingen GmbH | 04/26/2019SE |
| K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…MSX · Traditional | Current Health , Ltd. | 03/27/2019SE |
| K183238 | BeneVision Central Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 03/13/2019SE |
| K180430 | Digistat Smart CentralMSX · Traditional | Ascom Ums Srl Unipersonale | 11/23/2018SE |
| K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…MSX · Traditional | Snap40, Ltd. | 11/14/2018SE |
| K180566 | Unite Connect for Clinical SystemsMSX · Special | Ascom Sweden AB | 04/03/2018SE |
| K173203 | Athena GTX Device Management Suite (ADMS) SoftwareMSX · Traditional | Athena Gtx | 03/14/2018SE |
| K171322 | eCareManager 4.1MSX · Traditional | Visicu, Inc. | 08/03/2017SE |
| K162607 | BeneVision Central Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/20/2017SE |
| K153156 | eCareManager 4.0.1MSX · Traditional | Visicu, Inc. | 09/30/2016SE |
| K160862 | AirStrip RPMMSX · Traditional | Airstrip Technologies, Inc. | 09/19/2016SE |
| K161164 | CareEvent inclusive of the CareEvent Mobile Application accessoryMSX · Traditional | Philips Medical Systems | 06/24/2016SE |
| K151672 | Cerner CareAware Event ManagementMSX · Traditional | Cerner Corporation | 12/21/2015SE |
| K151006 | EarlySense Central Display Station (CDS)MSX · Traditional | Earlysense, Ltd. | 08/31/2015SE |
| K150632 | Hypervisor IX Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/06/2015SE |
| K140852 | Vectraplex CMSMSX · Traditional | Vectracor, Inc. | 01/30/2015SE |
| K142935 | CareEventMSX · Special | Philips Medical Systems | 01/15/2015SE |
| K141756 | Infinity Explorer Software, C700 for It Patient Vicinity WorkstationMSX · Traditional | Draeger Medical Systems, Inc. | 12/12/2014SE |
| K143057 | M3290B Philips IntelliVue Information Center iXMSX · Special | Philips Medical Systems | 12/03/2014SE |
| K132036 | Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016)MSX · Abbreviated | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 07/01/2014SE |
| K130707 | Isirona MagellanMSX · Traditional | Isirona, LLC | 11/20/2013SE |
| K130339 | Clinical Alert NotificationMSX · Traditional | Extension , Inc. | 07/11/2013SE |
| K121865 | Zoll Rescuenet 12-LEADMSX · Traditional | ZOLL Medical Corporation | 11/20/2012SE |
| K121712 | Airstrip RPM for Lifenet ConsultMSX · Traditional | Airstrip Technologies, Inc. | 11/20/2012SE |
| K121885 | Earlysense Central Display SystemMSX · Special | Earlysense, Ltd. | 09/10/2012SE |
| K112650 | Connexall Suite of Software ProductsMSX · Traditional | Connexall USA, Inc. | 02/01/2012SE |
| K112282 | M Visum Alert Alarm Management SystemMSX · Traditional | Mvisum, Inc. | 11/04/2011SE |
| K111296 | Zoll RescuenetlinkMSX · Traditional | Zoll Medical Corporation, World Wide Headquarters | 10/27/2011SE |
| K112047 | Amcom Commtech MessengerMSX · Traditional | Amcom Software,Inc. | 09/13/2011SE |
| K111215 | Ascom Mobile Monitoring Gateway (MMG)MSX · Traditional | Ascom (Sweden) AB | 07/05/2011SE |
| K110521 | Everon Central Display Station (CDS)MSX · Special | Earlysense, Ltd. | 04/19/2011SE |
| K103634 | Ascom Clinicalconnex CardiomaxMSX · Traditional | Ascom (Us), Inc. | 02/23/2011SE |
| K102974 | Intellisphere Event Managment System Rel. 10.00MSX · Traditional | Philips Medical Systems | 01/04/2011SE |
| K102757 | Lifenet SystemMSX · Special | Physio-Control, Inc. | 11/05/2010SE |
| K100376 | Everon Central Display Station - CDS, Model Version 1.0.0MSX · Traditional | Earlysense, Ltd. | 08/06/2010SE |
| K093925 | Lifenet SystemMSX · Special | Physio-Control, Inc. | 01/12/2010SE |
| K091176 | Philips Telemedicine Server/System, Model 861441MSX · Traditional | Philips Medical Systems | 11/13/2009SE |
| K080192 | Hypervisor Vi Central Monitoring System (Including TMS)MSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/03/2008SE |
| K071391 | Philips Heartstart 12 Lead Transfer Station, Model 989803142521MSX · Traditional | Philips Medical Systems, Inc. | 09/07/2007SE |
| K071047 | Masimo Patient Safety NetMSX · Traditional | Masimo Corporation | 06/08/2007SE |
| K070204 | Link to Acuity Clinician NotifierMSX · Special | Welch Allyn Protocol, Inc. | 03/23/2007SE |
| K070421 | Datex-Ohmeda S/5 Device Interfacing Solution, N-DISXXXX..01 with N-DISVENT..02MSX · Special | GE Healthcare | 03/13/2007SE |
| K061428 | PMP4 ApplicationMSX · Traditional | Card Guard Scientific Survival , Ltd. | 10/16/2006SE |
| K062278 | Spacelabs Medical Clinical Event Interface, Model 91847MSX · Special | Spacelabs Medical, Inc. | 09/19/2006SE |
| K061932 | Bernoulli Management System (MS) SoftwareMSX · Traditional | Cardiopulmonary Corp. | 09/14/2006SE |
| K061994 | Web Viewer, Pocket Viewer and Cellular Viewer with L- WEB05 SoftwareMSX · Special | GE Healthcare | 08/11/2006SE |
| K060254 | Modification to Infinity ExplorerMSX · Special | Draeger Medical Systems, Inc. | 04/04/2006SE |
| K052975 | Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5…MSX · Special | GE Healthcare | 01/20/2006SE |
| K052854 | Lifenet Exchange SystemMSX · Traditional | Medtronic Emergency Response Systems, Inc. | 01/20/2006SE |
| K052972 | Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3MSX · Special | GE Healthcare | 12/29/2005SE |
| K051634 | Datex-Ohmeda S/5 Device Interfacing SolutionMSX · Special | GE Healthcare | 07/19/2005SE |
| K051283 | Modification to Bernoulli Ventilator Management System SoftwareMSX · Special | Cardiopulmonary Corp. | 06/23/2005SE |
| K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsMSX · Special | Philips Medizin Systeme Boblingen GmbH | 11/12/2004SE |
| K042771 | GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3MSX · Special | Datex-Ohmeda | 10/15/2004SE |
| K040945 | Modification to Infinity ExplorerMSX · Special | Draeger Medical Systems, Inc. | 05/12/2004SE |
| K033281 | Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03 SoftwareMSX · Traditional | Datex-Ohmeda | 11/26/2003SE |
| K033078 | Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 SoftwareMSX · Special | Datex-Ohmeda | 10/29/2003SE |
| K032582 | Unity Network Patient Data ServerMSX · Traditional | Ge Medical Systems Information Technologies | 09/17/2003SE |
| K032346 | Unity Network Is Patient ViewerMSX · Special | Ge Medical Systems Information Technologies | 08/05/2003SE |
| K030615 | Infinity ExplorerMSX · Special | Siemens Medical Solutions USA, Inc. | 03/21/2003SE |
| K023497 | Datex-Ohmeda S/5 Web Viewer with L-6WV02 SoftwareMSX · Special | Datex-Ohmeda | 11/04/2002SE |
| K022507 | Datex-Ohmeda S/5 Network and Central '02MSX · Special | Datex-Ohmeda | 08/23/2002SE |
| K020661 | Unity Is Patient ViewerMSX · Traditional | General Electric Medical Systems Information Techn | 05/24/2002SE |
| K020524 | Patientnet Monitoring SystemMSX · Special | General Electric Medical Systems Information Techn | 03/20/2002SE |
| K020018 | Modification to Bernoulli Ventilator Management System SoftwareMSX · Traditional | Cardiopulmonary Corp. | 02/21/2002SE |
| K013387 | Datex-Ohmeda S/5 Web ViewerMSX · Traditional | Datex-Ohmeda | 01/08/2002SE |
| K013246 | Datex-Ohmeda S/5 Network and Central '01MSX · Traditional | Datex-Ohmeda | 12/11/2001SE |
| K012531 | Datex-Ohmeda S/5 Device Interfacing Solution, N-DisxxxxMSX · Traditional | Datex-Ohmeda | 11/02/2001SE |
| K013156 | Modification to Alarmview Wireless Data Network SystemMSX · Special | Data Critical Corp. | 10/19/2001SE |
| K012171 | Modification to: Argus System-Continuous Expert Care Network W/Smart AlramsMSX · Special | Visicu, Inc. | 07/24/2001SE |
| K012005 | Modification to Alarmview Wireless Data Network SystemMSX · Special | Data Critical Corp. | 07/24/2001SE |
| K011999 | Modification to Flexview Clinical Monitoring SystemMSX · Special | Data Critical Corp. | 07/24/2001SE |
| K010912 | Alarmview Wireless Data Network SystemMSX · Special | Data Critical Corp. | 04/05/2001SE |
| K003998 | Flexview Clinical Monitoring SystemMSX · Special | Data Critical Corp. | 03/07/2001SE |
| K001972 | Argus System-Continuous Expert Care NetworkMSX · Traditional | Visicu, Inc. | 10/27/2000SE |
| K000647 | Datex-Ohmeda Network and CentralMSX · Traditional | Datex-Ohmeda, Inc. | 07/13/2000SE |
| K994430 | Impact.Wf Mobile Waveform Receiving SystemMSX · Traditional | General Electric Medical Systems Information Techn | 03/28/2000SE |
| K992749 | Ultraview Waveform Pager System, Model 91841MSX · Traditional | Spacelabs Medical, Inc. | 01/14/2000SE |
| K992848 | Alarmview SystemMSX · Traditional | Data Critical Corp. | 11/19/1999SE |
| K990378 | Statview SystemMSX · Traditional | Data Critical Corp. | 09/20/1999SE |
| K982342 | Dinamap MPS Select Portable MonitorMSX · Traditional | Critikon Company, LLC | 08/14/1998SE |
| K973527 | Cardio-Pager SystemMSX · Traditional | Data Critical Corp. | 03/31/1998SE |
| K973640 | TS2000 Medical Device MonitorMSX · Traditional | Trincore Systems, Inc. | 03/12/1998SE |
| K973318 | Mobimed System, (Pegasus and Polaris)MSX · Traditional | Ortivus Us, Inc. | 02/19/1998SE |
| K974101 | Datex-Engstrom NetworkMSX · Traditional | Datex-Engstrom, Inc. | 02/06/1998SE |
| K974567 | Hewlett-Packard M2605A Viridia Wave ViewerMSX · Traditional | Hewlett-Packard Co. | 01/20/1998SE |
| K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMSX · Traditional | Marquette Electronics, Inc. | 11/13/1997SE |
| K962473 | (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and…MSX · Traditional | Data Critical Corporation | 11/06/1997ST |
| K972880 | MDP2000 Medical Data ProcessorMSX · Traditional | Vidco, Inc. | 10/22/1997SE |
| K971683 | Wireless Lan (Local Area Network) - Wireless EthernetMSX · Traditional | Marquette Electronics, Inc. | 10/22/1997SE |
| K971569 | Dinamap MPS Portable MonitorMSX · Traditional | Johnson & Johnson Medical, Inc. | 09/19/1997SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0920-2026 Class II | Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as…When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience… | Mindray DS USA, Inc. dba Mindray North… | 11/18/2025Open, Classified |
| Z-1387-2024 Class II | CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade)…It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom… | Philips North America | 02/28/2024Open, Classified |
| Z-0549-2022 Class II | eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3…eCareManager (eCM) Sentry Score software not approved for use | Philips North America Llc | 01/03/2022Terminated |
| Z-2108-2021 Class III | 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model…Telepack may not power on when using the 3AA battery cradle. | Mindray DS USA, Inc. dba Mindray North… | 05/27/2021Terminated |
| Z-1254-2021 Class II | Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n…BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes.… | Mindray DS USA, Inc. dba Mindray North… | 02/22/2021Open, Classified |
| Z-0532-2018 Class II | Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1…Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central… | Spacelabs Healthcare Inc | 01/17/2018Terminated |
| Z-0278-2018 Class II | Automated External Defibrillator - HeartStart MRx Monitor/DefibrillatorPhilips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause… | Philips Electronics North America Corporation | 09/28/2017Terminated |
| Z-0554-2018 Class II | TD60 Transmitter battery charger used with the BeneVision Central Station, Part number…A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to… | Mindray DS USA, Inc. dba Mindray North… | 07/14/2017Terminated |
| Z-1638-2016 Class II | Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for…Due to a malfunction of software, the secondary module will not automatically take over messaging if the… | Ascom US, INC. | 12/10/2015Terminated |
| Z-0582-2016 Class II | Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3…Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuous trap… | Vidco, Inc. | 11/08/2015Terminated |
| Z-0399-2016 Class II | The eCareManager system. Software intended for use in data collection, storage and…A software defect may cause incorrect medication order change. If the user decides to edit the order prior… | Visicu, Inc. | 03/27/2015Terminated |
| Z-0798-2013 Class II | Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part…Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG… | Mindray DS USA, Inc. d.b.a. Mindray North… | 11/28/2012Terminated |
| Z-1474-2012 | Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product…Three versions of software for the eCareManager failed to display anticoagulants on the medications screen.… | Visicu, Inc. | 02/22/2012Terminated |
| Z-0630-2013 Class II | DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The…There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe… | Mindray DS USA, Inc. d.b.a. Mindray North… | 05/12/2011Terminated |
| Z-2211-2010 | DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and…The iCentral or iCentral client v5.0.2 with HP xw 4400 and 4600 may spontaneously shutdown, causing… | Ge Healthcare, Llc | 06/25/2010Terminated |
| Z-1558-2009 | Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5 Device…GE Healthcare has recently become aware of an issue in the calculations associated with Datex-Ohmeda S/5… | GE Medical Systems, LLC | 05/08/2009Terminated |
| Z-1039-2009 | GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05…GE Healthcare is providing information about two issues associated with iCentral L-NETO5 and L-NETC05 v4.3… | GE Healthcare | 01/26/2009Terminated |
| Z-0213-2009 | GE Healthcare, Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer…Issue 1 -Possible failure of CIC Pro audible alarms: Requests for telemetry defaults from Mobile Care Server… | GE Healthcare | 07/16/2008Terminated |
| Z-1161-2008 | S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and…Failure to alarm: An active monitor could become disconnected from the unit without any notification or alarm. | GE Healthcare | 12/13/2007Terminated |