Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Cardiovascular · 21 CFR 870.2300
Recent MDR events
3,110 adverse event reports on file
- CARDIAC MONITOR, INCL. CARDIOTACHOMETER AND RATE ALARMJul 2, 2026Malfunction25689747
- ZM-540PAJun 30, 2026MalfunctionNihon Kohden Corporation8030229-2026-06792
- ZM-531PAJun 25, 2026MalfunctionNihon Kohden Corporation8030229-2026-06764
- NIHON KOHDEN TELEMETRY PACKJun 22, 2026MalfunctionNihon Kohden America, Inc.MW5189680
- ZM-540PAJun 15, 2026MalfunctionNihon Kohden Corporation8030229-2026-06738
- ZM-531PAMay 26, 2026MalfunctionNihon Kohden Corporation8030229-2026-06655
- ZM-531PAMay 22, 2026MalfunctionNihon Kohden Corporation8030229-2026-06570
- ZM-530PAMay 21, 2026MalfunctionNihon Kohden Corporation8030229-2026-06635
- ZM-531PAMay 12, 2026MalfunctionNihon Kohden Corporation8030229-2026-06599
- ZM-531PAMay 5, 2026MalfunctionNihon Kohden Corporation8030229-2026-06584
Event type breakdown
Recalls
11 recall events for this product code
- Murata Vios, Inc.Open, ClassifiedMar 6, 2025
Vios Monitoring System Bedside Monitor Model BSM2050
Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.
Z-1292-2025 · View FDA record ↗ - Murata Vios, Inc.Open, ClassifiedFeb 12, 2025
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
Z-1169-2025 · View FDA record ↗ - Murata Vios, Inc.Open, ClassifiedJan 30, 2025
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.
Z-1069-2025 · View FDA record ↗ - Murata Vios, Inc.CompletedJan 16, 2025
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.
Z-0956-2025 · View FDA record ↗ - Ansar Group, Inc. Dba Ansar Medical Technologies, IncTerminatedAug 19, 2014
Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system.
The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate, resulting in no BP measured.
Z-2268-2014 · View FDA record ↗ - Mindray DS USA, Inc. d.b.a. Mindray North AmericaTerminatedFeb 24, 2012
V Series Monitor
A system database corruption may occur that causes the V Series Monitor to reset.
Z-1102-2012 · View FDA record ↗ - Datascope CorpTerminatedNov 23, 2005
Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological
Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.
Z-0176-06 · View FDA record ↗ - Datascope CorpTerminatedNov 23, 2005
Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiol
Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.
Z-0177-06 · View FDA record ↗ - Datascope CorpTerminatedSep 21, 2005
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.
Z-1567-05 · View FDA record ↗ - Datascope CorpTerminatedAug 6, 2005
Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.
Z-1104-05 · View FDA record ↗
Registered firms
292 firms currently registered for this product code
Gww
Gaertringen Baden-Wurttemberg, DE
Philips North America Llc
ANDOVER, MA, US
Philips North America Llc
Cambridge, MA, US
Ge Medical Systems Information Technologies
EL PASO, TX, US
Ge Medical Systems (china) Co., Ltd.
WUXI Jiangsu, CN
Philips Medizin Systeme Boeblingen Gmbh
BOEBLINGEN Baden-Wurttemberg, DE
Nihon Kohden America Fulfillment Center
Foothill Ranch, CA, US
Ge Healthcare Finland Oy
HELSINKI Uusimaa, FI
Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI, US
Ivy Biomedical Systems, Inc.
Branford, CT, US
Katmai Integrated Solutions
Brilliant, OH, US
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
Jpex Medical Equipment & Supplies, Inc.
Ronkonkoma, NY, US
Biointellisense Inc.
Redwood City, CA, US
Nihon Vinyl Cord Corporation - Kodama Second Factory
Honjo-shi Saitama, JP
Circadia Health, Inc.
El Segundo, CA, US
Edan Diagnostics, Inc.
San Diego, CA, US
Philips North America Llc
Export, PA, US
Masimo Corporation
Irvine, CA, US
Philips North America Llc
Murrysville, PA, US
Philips Electronics Ltd
Mississauga Ontario, CA
510(k) clearances
339 clearances for this product code
- Circadia Health, Inc.May 20, 2026
K261286 · The Circadia C300 System (C300)
- Circadia Health, Inc.Feb 3, 2026
K252676 · The Circadia C300 System (C300)
- Sleepiz AGJan 28, 2026
K253388 · Sleepiz One+ (Model 2.5)
- Sleepiz AGJul 29, 2025
K251364 · Sleepiz One+ (2.5)
- Circadia Technologies, Ltd.May 30, 2024
K234003 · The Circadia C200 System
- Murata Vios, Inc.Mar 22, 2024
K232354 · Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
- Neteera Technologies , Ltd.Feb 9, 2024
K231733 · Neteera 130H-Plus Vital Sign Monitoring Sensor
- Sleepiz AGAug 18, 2023
K223163 · Sleepiz One+