Panels › Cardiovascular › Product code MHX · Class 2
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation 870.1025
16510(k)s in 12 months (431 all time)
41recalls in 12 months (294 all time)
277recalls that name a 510(k)
Top companies in MHX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2017 | Philips Electronics North America Corporation NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383) Terminated |
MHX | K122439 |
| Apr 28, 2017 | Mindray DS USA, Inc. dba Mindray North America TI Transport Monitor/Module Battery Pack
Product Usage:
intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters. Terminated |
MHX | K152902 |
| Mar 28, 2017 | Draegar Medical Systems, Inc. Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853.
Product Usage:
The devices are inte Terminated |
MHX | K152407 |
| Mar 28, 2017 | Draegar Medical Systems, Inc. Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus.
Product Usage:
The devices are intended to be used in the environment where p Terminated |
MHX | K152407 |
| Mar 28, 2017 | Draegar Medical Systems, Inc. Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus.
Product Usage:
The devices are intended to be used in the environment where pat Terminated |
MHX | K152407 |
| Mar 20, 2017 | Nihon Kohden America Inc Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA). Terminated |
MHX | K151080 |
| Jan 17, 2017 | Philips Electronics North America Corporation Philips Efficia CMS200 Central Monitoring System; 863352
The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, paramete Terminated |
MHX | K160951 |
| Nov 2, 2016 | Spacelabs Healthcare Inc Xhibit Central Station, Model 96102.
Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthc Terminated |
MHX | K122146 |
| Sep 26, 2016 | Spacelabs Healthcare Inc Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280.
Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. Terminated |
MHX | K141156 |
| Sep 26, 2016 | Spacelabs Healthcare Inc Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2.
Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. Terminated |
MHX | K122146 |
| Sep 19, 2016 | Philips Electronics North America Corporation Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g
Product Number: 865352
Exchange part:
453564262491
453564262511
453564615311
453564615331
453564262571
453564262591
Exchange part Terminated |
MHX | K113125 |
| Sep 19, 2016 | Philips Electronics North America Corporation Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz)
Product Number: 865351
Worldwide Except USA
Exchange part:
453564262491
453564262511
453564615311
453564615331
4535642 Terminated |
MHX | K113125 |
| Sep 19, 2016 | Philips Electronics North America Corporation Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz)
Product Number: 865350
Exchange part:
453564262491
453564262511
453564615311
453564615331
453564262571
453564262 Terminated |
MHX | K113125 |
| Sep 8, 2016 | Mindray DS USA, Inc. dba Mindray North America TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China Terminated |
MHX | K150632 |
| Jul 26, 2016 | Philips Electronics North America Corporation IntelliVue Patient Monitor
Product Usage:
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor Terminated |
MHX | K131872 K141015 +1 |
| Jun 23, 2016 | Mindray DS USA, Inc. dba Mindray North America Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12 Terminated |
MHX | K143195 |
| Jun 23, 2016 | Edan Diagnostics EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors
EtCO2 module is an optional component of the Terminated |
MHX | K110922 K113623 +2 |
| Mar 28, 2016 | Spacelabs Healthcare Inc The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor. Terminated |
MHX | K141156 |
| Mar 9, 2016 | Mindray DS USA, Inc. dba Mindray North America Panorama Patient Monitoring Network
Mindray DS USA
The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monito Terminated |
MHX | K150882 |
| Feb 26, 2016 | Spacelabs Healthcare Inc Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient mo Terminated |
MHX | K122146 |
| Feb 23, 2016 | Philips Electronics North America Corporation Philips Healthcare IntelliVue Info Center iX, B.0, 866389
Physiological, Patient Monitor (With Arrhythmia Detection or Alarm) Terminated |
MHX | K102495 |
| Feb 23, 2016 | Philips Electronics North America Corporation Philips Healthcare PIIC Classic Upgrade, 866117
Physiological, Patient Monitor (With Arrhythmia Detection or Alarm) Terminated |
MHX | K102495 |
| Feb 23, 2016 | Philips Electronics North America Corporation Philips Healthcare IntelliVue Info Center iX, A.0 866023 Terminated |
MHX | K102495 |
| Jan 29, 2016 | Mindray DS USA, Inc. dba Mindray North America Panorama Patient Monitoring Network.
Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910.
The Pa Terminated |
MHX | K150082 |
| Jan 16, 2016 | Fukuda Denshi USA, Inc. Fukuda Denshi patient monitor model DS-8100M and DS-8100N.
The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is
meant to acquire and monitor physiological signals from patients. Terminated |
MHX | K134046 |
| Jan 4, 2016 | Philips Electronics North America Corporation Philips IntelliVue Module Measurement X2
Model: M3002A Terminated |
MHX | K150310 |
| Jan 4, 2016 | Philips Electronics North America Corporation Philips IntelliVue Measurement Module X1
Model: M3001A Terminated |
MHX | K150310 |
| Dec 4, 2015 | Philips Medical Systems, Inc. Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue:
866023 IntelliVue Info Center iX
866024 PIIC iX Upgrade
866117 PIIC Classic Upgrade
The intended us Terminated |
MHX | K102495 |
| Sep 4, 2015 | Mindray DS USA, Inc. dba Mindray North America Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)
Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological Terminated |
MHX | K092449 |
| May 26, 2015 | Mindray DS USA, Inc. dba Mindray North America Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01.
The Panorama Network includes the Panorama Telemetry System Terminated |
MHX | K142601 |
| May 13, 2015 | Spacelabs Healthcare Inc Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports i Terminated |
MHX | K120616 |
| May 12, 2015 | GE Healthcare GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). Terminated |
MHX | K092027 K102239 +3 |
| Apr 29, 2015 | Nihon Kohden America Inc Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40.
The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital Terminated |
MHX | K023475 |
| Mar 16, 2015 | Mindray DS USA, Inc. dba Mindray North America Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms)
Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. Terminated |
MHX | K091834 |
| Feb 24, 2015 | Spacelabs Healthcare Inc Spacelabs Healthcare qube Compact Monitor, Model 91390.
The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated b Terminated |
MHX | K120616 |
| Feb 24, 2015 | Spacelabs Healthcare Inc Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, an Terminated |
MHX | K112962 |
| Dec 19, 2014 | Mindray DS USA, Inc. dba Mindray North America DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors .
Intended to be used for Terminated |
MHX | K092449 |
| Oct 22, 2014 | Mortara Instrument, Inc Mortara Surveyor S12 and Surveyor S19 Patient Monitors.
Product Usage:
They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood press Terminated |
MHX | K123556 |
| Oct 21, 2014 | Philips Medical Systems, Inc. Philips IntelliVue Monitors with software revisions J.21.03, J.21.19.
Model Product
MP5 M8105A;
MP5SC M8105AS;
MP5T M8105AT;
MP5 Upgrade M8105AU ;
MP5SC Upgrade 866327
The monitors are intend Terminated |
MHX | K122439 K131913 |
| Oct 21, 2014 | Mindray DS USA, Inc. dba Mindray North America Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1
The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. Terminated |
MHX | K132026 |
| Oct 9, 2014 | GE Healthcare, LLC GE Healthcare Carescape Patient Data Module Terminated |
MHX | K071073 |
| Sep 25, 2014 | Spacelabs Healthcare Inc Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option Terminated |
MHX | K102422 |
| Sep 4, 2014 | Spacelabs Healthcare Inc ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment. Terminated |
MHX | K121480 |
| Jul 24, 2014 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. Terminated |
MHX | K102239 |
| Jul 21, 2014 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. Terminated |
MHX | K092027 K131223 +3 |
| Jul 16, 2014 | Mindray DS USA, Inc. dba Mindray North America V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Dr Terminated |
MHX | None listed |
| Jul 2, 2014 | Nihon Kohden America Inc CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201
For cardiac and vital signs monitoring for multiple patients. Terminated |
MHX | K102376 |
| Jun 23, 2014 | Spacelabs Healthcare Inc Spacelabs Healthcare Qube Compact Monitor, Model 91390.
Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors vi Terminated |
MHX | K120616 |
| Jun 11, 2014 | Philips Healthcare Inc. Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor. Terminated |
MHX | K102495 |
| Jun 10, 2014 | Philips Medical Systems, Inc. IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352 Terminated |
MHX | K103646 K113125 |
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