Life Scope TRRecalls & reported problems across all models

We found 3 models of Life Scope TR by Nihon Kohden Corporation in the FDA's device registry (GUDID). Together they are named in 286 adverse event reports in the FDA's MAUDE database, received between May 12, 2016 and Sep 22, 2026 — classified as 4 deaths, 1 injury, 278 malfunctions.

The most frequently reported specific device problem is “Output Problem” (96 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Life Scope TR problems

Life Scope TR models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Life Scope TR MU-631RA

  MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  3 deaths169 reports
• Life Scope TR MU-671RA

  MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  69 reports
• Life Scope TR MU-651RA

  MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  1 death48 reports

Recent Life Scope TR adverse event reports

The 15 most recent reports across all models, 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 unusual arrhythmia alarms on the Bedside Monitor (BSM), which displayed HR/PR as a single parameter. Technical Support (TS) found the Sync Source in the SpO2 settings was set to ECG and changed it to SpO2, initially resolving the alarms. The issue later returned, with PR displayed and doubled. No reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855706 ↗
• MalfunctionAug 14, 2026No Audible Alarm; Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50257231 ↗
• MalfunctionAug 12, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221407 ↗
• MalfunctionJul 29, 2026Output Problem

  The Biomedical Engineer (BME) reported that when trying to export data it leads to a different screen that has EKG and respiratory instead of exporting the data. They stated the touch screen on the Bedside Monitor (BSM) is malfunctioning. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50069285 ↗
• MalfunctionJul 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25803488 ↗
• MalfunctionJul 1, 2026Output Problem

  THE CUSTOMER REPORTED THAT THE BIOMED WAS INFORMED BY A MONITOR TECHNICIAN THAT SOMEONE AT THE FACILITY MAY KNOW THE PASSWORD AND MAY HAVE CHANGED SETTINGS THAT RESULTED IN ALARMS BEING TURNED OFF. THIS WAS DISCOVERED WHEN ILYANA, MONITOR TECHNICIAN NOTICED A WAVEFORM THAT SHOULD HAVE GENERATED AN ALARM BUT DID NOT. UPON REVIEWING THE BEDSIDE MONITOR SETTINGS, THEY FOUND THAT THE CONFIGURATION DID NOT MATCH THE SETTINGS OF THE OTHER BEDSIDE MONITORS IN THE DEPARTMENT. THE END-USER CAN ADJUST LIMITS AS NEEDED TO OPTIMIZE MONITORING OF EACH PATIENT, AS WELL AS LIMIT ALARM FATIGUE. THE LOWEST THAT THE SPO2 LOWER LIMIT CAN BE ADJUSTED IS 50. IF THERE WAS A READING OF 18% THAT WAS WITNESSED, THIS WOULD HAVE BEEN THE PATIENT'S SPO2 READING, NOT A LOWER LIMIT SETTING. THIS DESAT WOULD HAVE TRIGGERED AN ALARM, WHICH COULD HAVE BEEN SILENCED AT THE BEDSIDE OR CNS. ANOTHER POSSIBILITY IS THAT THE SPO2 LOWER LIMIT COULD HAVE BEEN SELECTED AS "OFF." IN THIS CASE, THE LOWER LIMIT SETTING WOULD BE IRRELEVANT, AND THE MONITOR WOULD NOT ALARM FOR A DESAT. THE LOGS ARE BEING COLLECT TO SEE WHAT HAPPENED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682242 ↗
• MalfunctionJun 24, 2026Erratic or Intermittent Display; Display or Visual Feedback Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE LEFT SIDE OF THE BEDSIDE MONITOR (BSM) SCREEN WAS BLANK AND DID NOT DISPLAY NUMERICAL VALUES. THE ISSUE OCCURRED DURING A SURGICAL CASE, AND THE SURGEON WAS UNABLE TO REBOOT THE BSM; HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25608520 ↗
• MalfunctionJun 15, 2026No Display/Image; Display or Visual Feedback Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) DISPLAY WAS BLACK EVEN THOUGH THE POWER WAS ON AND THEY COULD SEE LIGHTS AND ALARMS. NOT IN PATIENT USE AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505620 ↗
• MalfunctionJun 8, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE VITALS DISAPPEAR WHILE MONITORING ON THIS BEDSIDE MONITOR (BSM). THIS UNIT WILL RANDOMLY DROP OUT ITS WAVEFORMS AND THEN IT WILL COME BACK A FEW MINUTES LATER. WHEN WAVEFORM DROPS OUT, ITS MATCHING NUMERICAL VALUE ALSO DISAPPEARS AND THEN REAPPEARS WHEN THE WAVEFORM RETURNS. CUSTOMER SPECIFICALLY CALLED OUT SEEING THIS BEHAVIOR ON ECG AND SPO2, WHERE NIBP WOULD REMAIN IN ITS POSITION, NOT SHIFTING TO THE PRIMARY SLOT, BUT ECG AND SPO2 WOULD DISAPPEAR FOR A FEW MINUTES BEFORE RETURNING. THIS BEHAVIOR STARTS WITHIN THE FIRST MINUTE OR TWO OF OPERATION. THIS IS A STANDALONE UNIT AND IS NOT MONITORED BY A CENTRAL NURSE'S STATION (CNS) OR REMOTE NETWORK STATION (RNS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428470 ↗
• MalfunctionJun 8, 2026Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) UNEXPECTEDLY REBOOTED ITSELF WHILE MONITORING A PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425747 ↗
• DeathJun 7, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD A PATIENT DEATH WHILE THEY WERE CONNECTED TO THIS MONITOR. IT APPEARS THAT THE PATIENT WAS NOT ADMITTED TO THIS BEDSIDE MONITOR (BSM) AT ALL OR AT LEAST NOT CORRECTLY. THEY HAVE NO FULL DISCLOSURE DATA AT THE CENTRAL NURSE'S STATION (CNS) OR BEDSIDE MONITOR (BSM), AND THE PATIENT NAME/ MRN IS NOT IN THE DISCHARGED PATIENTS LIST, EVEN THOUGH THERE ARE DISCHARGES FROM LONGER AGO THAN THIS INCIDENT IN THAT LIST AND THERE WAS NO PATIENT DATA GOING TO EPIC EMR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25422538 ↗
• InjuryMay 26, 2026Unintended Movement; Device Fell

  THE PATIENT REPORTED THAT WHILE BEING MONITORED ON THE BEDSIDE MONITOR (BSM), THE DEVICE FELL ON HIS HEAD, CAUSING HEAD LACERATIONS AND A CONCUSSION. HE WAS CALLING IN TO OBTAIN THE WEIGHT OF THE DEVICE.

  Patient problems: Concussion; Head Injury; Laceration(s)

  MAUDE report 25285259 ↗
• MalfunctionMay 11, 2026Application Program Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT ONE OF THEIR BEDSIDE MONITORS WAS DISCHARGED AFTER WAKING UP A PATIENT. HE WANTED TO KNOW IF THERE WAS ANY REASON THAT THE BEDSIDE WOULD DISCHARGE A PATIENT ON ITS OWN. TECH SUPPORT (TS) INFORMED THEM THAT THERE SHOULD NOT BE ANY REASON FOR THE PATIENT TO GET DISCHARGED. IT IS POSSIBLE THAT IT WAS A USER ERROR AND THAT SOMEBODY HAD DISCHARGED THE PATIENT FROM THE CNS OR AT THE BEDSIDE MONITOR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143839 ↗
• MalfunctionMay 11, 2026Communication or Transmission Problem; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) IS GOING INTO COMMUNICATION LOSS (COMM LOSS) INTERMITTENTLY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143188 ↗
• MalfunctionMay 11, 2026Power Problem; Complete Loss of Power

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) SHUT DOWN WHILE MONITORING A PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135652 ↗

Other Nihon Kohden Corporation products

• Life Scope PT3 models · 203 reports
• Life Scope VS3 models · 65 reports · 1 recall
• Nihon Kohden Life Scope G7 Bedside Monitoring System2 models · 60 reports
• cap-ONE3 models · 3 reports · 1 recall
• Nihon Kohden Life Scope G5 Bedside Monitoring System2 models · 41 reports
• Neurofax2 models · 29 reports