Nihon Kohden SVM-7200 Series Vital Signs Monitor SVM-7250Recalls & reported problems
Nihon Kohden Corporation · Vital Signs Monitor with Nellcor SpO2 technology of SVM-7200 Series Vital Signs Monitor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04931921005897), received between Jul 11, 2025 and Jul 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Readings” (1 report).
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
- High Readings1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Output Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NIPB MODULE FOR THE VITAL SIGNS MONITOR WAS READING ABOUT 10 POINTS TOO HIGH AND THE READINGS WERE INCONSISTENT. THEY WERE USING NK CABLES AND CUFFS. THE DEVICE WAS NOT IN PATIENT USE AT THE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22485131 ↗
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- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls3 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 reports
- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
- Change Healthcare Cardiology Hemo 14.2Change Healthcare Canada Company · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
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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