Life Scope VSRecalls & reported problems across all models
Nihon Kohden Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Life Scope VS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 65
- Deaths reported
- 3
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of Life Scope VS by Nihon Kohden Corporation in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Jan 31, 2018 and Sep 25, 2026 — classified as 3 deaths, 62 malfunctions.
The most frequently reported specific device problem is “Output Problem” (23 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Reports received per month, all models
Life Scope VS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 29, 2024Open, Classified
Due to software issue the device may give false "SpO2 Probe Failure" alarm
Z-2025-2024 · Root cause: Software design · Recall details · FDA record ↗
Most reported Life Scope VS problems
Device problems
- Output Problem23
- Communication or Transmission Problem10
- Unintended Application Program Shut Down10
- Incorrect, Inadequate or Imprecise Result or Readings9
- Application Program Problem8
- Display or Visual Feedback Problem6
- Protective Measures Problem6
- Erratic or Intermittent Display3
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Life Scope VS models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Life Scope VS BSM-3572MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall20 reports
- Life Scope VS BSM-3532MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)3 deaths24 reports
- Life Scope VS BSM-3552MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)21 reports
Recent Life Scope VS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathSep 25, 2026Device Alarm System; Protective Measures Problem
The Biomedical Engineer (BME) reported a patient event involving a death while the patient was connected to the Bedside Monitor (BSM). The BME requested a review of the device logs to determine whether the monitor alarmed appropriately and whether a staff member silenced the alarm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897036 ↗MalfunctionSep 9, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699208 ↗MalfunctionJul 29, 2026False Alarm; Erratic or Intermittent Display; Output Problem
The Biomedical Engineer (BME) reported intermittent ECG issues with the Bedside Monitor (BSM). No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068737 ↗MalfunctionJun 3, 2026Intermittent Communication Failure
THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR (BSM) WAS EXPERIENCING INTERMITTENT COMMUNICATION LOSS, WHILE ADJACENT MONITORS DID NOT LOSE COMMUNICATION. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25373372 ↗MalfunctionMay 19, 2026Electrical /Electronic Property Problem; Unexpected Shutdown
THE CUSTOMER REPORTED THAT 3 MONITORS SHUTDOWN WHILE IN PATIENT USE AND WHEN THEY BOOTED BACK UP, THEY DISPLAYED AN ERROR. ROOMS 1 (SN (B)(6)), 6 (SN (B)(6)), AND 7 (SN (B)(6)) IN THE (B)(6) DEPARTMENT. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216930 ↗MalfunctionMay 18, 2026Power Problem; Complete Loss of Power
THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THIS WAS ONE OF 3 LIFE SCOPE MONITORS THAT SHUT DOWN WHILE IN PATIENT USE AND THEN GAVE A "DEVICE ERROR" MESSAGE WHEN THEY BOOTED BACK UP. ALL 3 DEVICES DROPPED OUT AT THE SAME TIME. THE OTHER 2 DEVICES WERE REPORTED IN TICKETS 300433550 AND 300433765. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25206265 ↗MalfunctionMay 18, 2026Power Problem; Complete Loss of Power
THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THIS WAS ONE OF 3 LIFE SCOPE MONITORS THAT SHUT DOWN WHILE IN PATIENT USE AND THEN GAVE A "DEVICE ERROR" MESSAGE WHEN THEY BOOTED BACK UP. ALL 3 DEVICES DROPPED OUT AT THE SAME TIME. THE OTHER 2 DEVICES WERE REPORTED IN TICKETS (B)(4) AND (B)(4). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25205279 ↗MalfunctionApr 27, 2026Application Program Problem; Unintended Application Program Shut Down
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) SPONTANEOUSLY REBOOTED WHILE IT WAS IN PATIENT USE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24999811 ↗MalfunctionApr 17, 2026Application Program Problem; Unintended Application Program Shut Down
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITORS ARE RANDOMLY POWERING OFF. THEY HAVE TO REBOOT THE MONITOR TO POWER THEM ON. THE STATED THE UNIT DID NOT HAVE ANY LIGHTS WHILE IT WAS POWERED OFF. THEY DO NOT HAVE A BATTERY. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24918128 ↗MalfunctionMar 16, 2026No Display/Image; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) WAS NOT PROVIDING THE ECG OR SPO2 READINGS UNTIL THEY REBOOTED THE UNIT. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603947 ↗MalfunctionFeb 27, 2026Display or Visual Feedback Problem; Image Display Error/Artifact
THE CUSTOMER REPORTED THAT THE ECG WAVEFORMS ARE ABNORMAL LOOKING. THE ISSUE WAS DISCOVERED DURING SETUP. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471221 ↗MalfunctionJan 30, 2026Display or Visual Feedback Problem; Image Display Error/Artifact
THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) WAS DISPLAYING ECG ARTIFACTS INTERMITTENTLY. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24220611 ↗MalfunctionDec 17, 2025Signal Artifact/Noise; Signal Artifact/Noise
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEIR CLINICAL STAFF WITNESSED THIS BEDSIDE MONITOR (BSM) HAD ARTIFACTS AND SHOWING ECG READINGS THAT WERE UNSTABLE, RESULTING IN A TACHYCARDIA ALARM. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828485 ↗MalfunctionNov 24, 2025Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE LIFE SCOPE MONITOR WAS IDLING ON A STANDBY SCREEN WHEN IT STARTED ALARMING AND REBOOTING, SHOWING A BLUE BLOCK MEMORY ERROR SCREEN. TECHNICAL SUPPORT (TS) TRIED TROUBLESHOOTING WITH THE BME, BUT WHEN TRYING TO LOAD THE SOFTWARE, IT GAVE A "WATCHDOG ERROR" MESSAGE BEFORE TRYING TO REBOOT. IT WOULD THEN OCCASIONALLY LOAD THE MONITORING SCREEN AND ALARM AND THEN DISPLAY THE BLUE BLOCK MEMORY ERRORS AGAIN. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23639740 ↗MalfunctionNov 7, 2025Communication or Transmission Problem; Intermittent Communication Failure; Communication or Transmission Problem; Intermittent Communication Failure
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE LIFE SCOPE MONITOR WAS IN INTERMITTENT COMM LOSS. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498360 ↗
Other Nihon Kohden Corporation products
All Nihon Kohden Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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