Nihon Kohden Life Scope G7 Bedside Monitoring System CU-172RRecalls & reported problems
Nihon Kohden Corporation · Core unit · Class 2
All models of Nihon Kohden Life Scope G7 Bedside Monitoring System (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nihon Kohden Life Scope G7 bedside monitor (CU-172R core unit) watches vital signs such as heart rate and blood pressure at the bedside. The 56 reports mostly describe the monitor giving no output, blank or wrong readings on screen, and its software freezing or failing to start; one report describes an erratic heart rate that missed beats in an operating room. No deaths and no injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 04931921004517), received between Feb 20, 2023 and Sep 22, 2026 — classified as 59 malfunctions.
The most frequently reported specific device problem is “Output Problem” (23 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Output Problem23
- Display or Visual Feedback Problem19
- Application Program Freezes or Fails to Launch13
- Application Program Problem11
- Incorrect, Inadequate or Imprecise Result or Readings7
- Unable to Obtain Readings5
- Image Display Error/Artifact4
- Erratic or Intermittent Display3
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
The Biomedical Engineer (BME) reported that a LVAD patient on a GZ transmitter was experiencing constant alarms (asystole, VTach, Pacer Non-capture, etc.) When the patient placed on a G7 Bedside Monitor (BSM), it also alarmed; however, there were more alarms when on the GZ. They also stated that the GZ had pacing spikes in the middle of the QRS complex that were not accurate and were not present on the 12-lead EKG. All types of lead placement were attempted to minimize the alarms, but the issue persisted. No reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849600 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564741 ↗MalfunctionAug 27, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
The NK Employee reported that the customer was unable to get an NIBP reading on the G7 Monitor in the Operating Room (OR). The Heart Rate (HR) was also erratic and missing beats. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50484324 ↗MalfunctionAug 24, 2026Output Problem
The Biomedical Engineer (BME) reported that the NIBP readings were inconsistent on this G7 Bedside Monitor. This unit gave several readings that were all over the place. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410357 ↗MalfunctionAug 24, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50409047 ↗MalfunctionJul 31, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50108002 ↗MalfunctionJul 22, 2026Display Difficult to Read; Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25906329 ↗MalfunctionJul 16, 2026Device Alarm System; Protective Measures Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25842909 ↗MalfunctionJul 16, 2026Device Alarm System; Protective Measures Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25841864 ↗MalfunctionJul 14, 2026Tactile Prompts/Feedback; No Tactile Prompts/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25817151 ↗MalfunctionJul 1, 2026Unable to Obtain Readings; Output Problem
THE NK EMPLOYEE (CAS MANAGER) REPORTED ON BEHALF OF THE ANESTHESIOLOGIST THAT THE NIBP FUNCTION ON THE G7 MONITOR WAS ONLY INTERMITTENTLY TAKING INTERVAL READINGS DURING A CASE, REQUIRING MANUAL DEPRESSING OF THE START/STOP BUTTON TO INITIATE THE BP MEASUREMENT. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680794 ↗MalfunctionJun 8, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT WHEN PRESSING THE NEW PATIENT BUTTON ON THE G7 MONITOR TO START THE NIBP INTERVAL FUNCTION, IT WOULD NOT ALWAYS START THE MEASUREMENT. THE CUFF WAS INFLATING, BUT THE BSMS WOULD TIME OUT WITH NO ERRORS. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25438010 ↗MalfunctionJun 8, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE NK'S EMPLOYEE (TSAM) REPORTED ON BEHALF OF THE BIOMEDICAL ENGINEER (BIOMED) THAT THE G7 MONITOR WAS GIVING ERRATIC ECG READINGS, THE NIBP FUNCTION WOULD NOT ALWAYS TAKE A PRESSURE, AND THE IBP VALUES WERE NOT TRANSFERRING TO EPIC. THEY ALSO REPORTED THAT THE ALARMS WOULD GO OFF VERY EASILY. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25437992 ↗MalfunctionMay 19, 2026Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THE TOUCHSCREEN ON THIS UNIT IS NONRESPONSIVE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25223016 ↗MalfunctionMay 18, 2026Display or Visual Feedback Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G7 MONITOR WAS EXPERIENCING FREEZING ISSUES. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25211370 ↗MalfunctionApr 13, 2026Communication or Transmission Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G7 MONITOR DISPLAYED A "COMM LOSS" WHILE IN PATIENT USE. THE G7 WAS CONNECTED TO A DRAGER ATLAN ANESTHESIA MACHINE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859637 ↗MalfunctionApr 2, 2026Tactile Prompts/Feedback; No Tactile Prompts/Feedback
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TOUCHSCREEN ON THE G7 MONITOR WAS INTERMITTENTLY REGISTERING FALSE TOUCHES, WHICH CAUSED THE MENU AND OTHER SETTINGS TO POP UP AS IF SOMEONE WAS CLICKING THEM. THEY WERE ABLE TO COMPLETE THE CASE, AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24771860 ↗MalfunctionMar 31, 2026Display or Visual Feedback Problem; Tactile Prompts/Feedback; No Tactile Prompts/Feedback; Key or Button Unresponsive/not Working
THE CUSTOMER REPORTED THAT THE TOUCHSCREEN ON THIS G7 UNIT WAS UNRESPONSIVE. THE ISSUE WAS DISCOVERED DURING SETUP. ACCORDING TO THE CUSTOMER, THE SAME ISSUE OCCURRED THE PREVIOUS WEEK (249024). THE UNIT WAS NOT IN PATIENT USE AT THE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746615 ↗MalfunctionMar 30, 2026Output Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G7 BEDSIDE MONITOR IS OPENING SCREENS ON ITS OWN, WITH NO ONE INTERACTING WITH THE BEDSIDE MONITOR. TECH SUPPORT (TS) NOTICED THE TWO SCREENS OPENING HAVE TOUCHKEYS AT THE BOTTOM OF THE DISPLAY IN NORMAL OPERATING MODE; THIS APPEARS TO BE PHANTOM TOUCHING. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24737358 ↗MalfunctionMar 30, 2026Output Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE UNIT WAS MISINTERPRETING THE PACEMAKER SPIKES. OUR NIHON KOHDEN CLINICAL APPLICATIONS SPECIALIST (CAS) REVIEWED THE VIDEO AND WAS UNABLE TO DETERMINE WHY THE PACER MARKS ARE MISPLACED. WAVE APPEARS STRONG BUT APPEARS THAT SOME OF THE PACER SPIKES ARE NOT IN THE APPROPRIATE LOCATIONS NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24736926 ↗MalfunctionMar 30, 2026Output Problem
THE BIOMEDICAL ENGINEER (BME) THE CUSTOMER REPORTED THAT THE THEIR CU-172RA INTERMITTENTLY REGISTERS TOUCH INPUT WHEN NO ONE IS TOUCHING THE SCREEN, CAUSING RANDOM TABS TO OPEN. THE BME REPORTED THAT THE ISSUE IS SPORADIC AND TEMPORARILY RESOLVES AFTER COMPLETELY POWERING OFF THE DEVICE AND REMOVING THE RECHARGEABLE BATTERIES. HOWEVER, THE ISSUE RETURNS ABOUT TWO WEEKS LATER AFTER THE REBOOT. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24736860 ↗MalfunctionMar 17, 2026Erratic or Intermittent Display
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G7 MONITOR HAD A PERSISTENT TOUCH BY THE SILENCE ALARM BUTTON. EACH TIME THIS OCCURRED, THE STAFF RESOLVED IT BY REBOOTING THE DEVICE, BUT THE ISSUE WOULD RETURN AFTER A SHORT TIME. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615908 ↗MalfunctionMar 10, 2026Output Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE A-LINE VALUE SPIKED, THEY WERE UNABLE TO CLEAR IT, AND THE VALUES WOULD NOT READ CORRECTLY FOLLOWING THE SPIKE. IT IS UNCLEAR HOW IT WAS INCORRECT OR HOW IT WAS DETERMINED TO BE INCORRECT. THE NURSE REMOVED AND REINSERTED THE BP CABLE AND THE ISSUE RESOLVED. THE CUSTOMER WAS UNABLE TO DUPLICATE THE ISSUE WITH A SIMULATOR, AND THEY HAVE HAD NO ISSUES SINCE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24565396 ↗MalfunctionMar 9, 2026Output Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR IS NOT DETECTING HR WITH PACING DETECTION ENABLED. IT IS FALSE ALARMING ASYSTOLE. WITH PACING DETECTION DISABLED, THEY ARE GETTING A HR AND THEY ASYSTOLE ALARM STOPS. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24553936 ↗MalfunctionJan 21, 2026Display or Visual Feedback Problem; Output Problem; No Visual Prompts/Feedback
THE CUSTOMER REPORTED THAT THE G7 BEDSIDE MONITOR HAD A BLACK SCREEN. TECH SUPPORT (TS) ASKED HER TO RESEAT THE POWER CORD BECAUSE A LOOSE CABLE COULD CAUSE THE MONITOR TO SHUT OFF HOWEVER THIS DID NOT RESOLVE THE ISSUE. WHEN UNPLUGGING THE POWER CORD, THE ALARM WENT OFF, SO THE DEVICE DEFINITELY HAD POWER, BUT THE SCREEN WAS BLACK. THE ISSUE HAS BEEN RESOLVED BY REMOVING THE BATTERIES AND FULLY SHUTTING THE MONITOR DOWN. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24141287 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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