Rad-97 9799Recalls & reported problems
Masimo Corporation · Rad-97 with NomoLine Capnography · Class 2
Quick summary
This Masimo Rad-97 patient monitor with NomoLine capnography tracks oxygen levels and breathing. There are 26 malfunction reports, with no deaths and no injuries reported. Reports mostly describe inaccurate or jumping readings, devices shutting down or resetting on their own, and connections dropping out; one report mentions smoke coming from the device. 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
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00843997012782), received between Jul 3, 2020 and Sep 30, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (8 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement8
- Unexpected Shutdown6
- Sensing Intermittently4
- Inappropriate or Unexpected Reset3
- Low Readings3
- Display or Visual Feedback Problem1
- Fire1
- High Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Audible Alarm; Sensing Intermittently
The customer reported that the device has an audio speaker failure and tb-20 intermittent connection issues. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941662 ↗MalfunctionSep 4, 2026Incorrect Measurement; Low Readings
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50604926 ↗MalfunctionSep 4, 2026Incorrect Measurement; Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50604842 ↗MalfunctionAug 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
The customer reported that the device is displaying inaccurate HR readings. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50422971 ↗MalfunctionJan 15, 2026Fire; Smoking
THE CUSTOMER REPORTED THE RAD-97 "CAUGHT ON FIRE" AND "BURN A HOLE THROUGH THE PLASTIC." PER ADDITIONAL INFORMATION OF THE REPORTED ISSUE, THE DEVICE "WAS BEING USED ON A PATIENT AT THE TIME" AND "THERE WAS SMOKE FROM THE DEVICE AND AN ELECTRICAL SMELL." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24079279 ↗MalfunctionNov 5, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE KEEPS SHUTTING OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23482212 ↗MalfunctionNov 5, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE KEEPS SHUTTING OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23482188 ↗MalfunctionSep 8, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
THE CUSTOMER REPORTED THAT THE DEVICE LOSES CONNECTION RANDOMLY. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22995012 ↗MalfunctionJun 9, 2025Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED "INACCURATE ETCO2 READING" ON THE RAD-97. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22172751 ↗MalfunctionFeb 20, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-97 POWERED OFF BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21428422 ↗MalfunctionFeb 7, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE UNIT WILL NOT RUN LONGER THAN 3 MINS OFF AC. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21337885 ↗MalfunctionNov 19, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE IS "INTERMITTENTLY SWITCHING OFF WHILE IN USE." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20730447 ↗MalfunctionDec 12, 2023Sensing Intermittently; Unexpected Shutdown; Sensing Intermittently; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-97 POWERED OFF BY ITSELF EVEN WHEN THE DEVICE BATTERY WAS FULLY CHARGED AND HAS AN INTERMITTENT PROBLEM WITH READING SPO2. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18314293 ↗MalfunctionMar 10, 2023Sensing Intermittently; Low Readings; Inappropriate or Unexpected Reset; Sensing Intermittently; Low Readings; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THE DEVICE WILL CYCLE ON AND OFF, HAS INTERMITTENT READINGS, AND WAS READING LOWER COMPARED TO A COMPETITOR'S DEVICE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16521649 ↗MalfunctionMar 10, 2023Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE HAS SIGNAL DROP OUTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16521540 ↗MalfunctionMar 4, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE WON'T READ CO2 AND BLOOD PRESSURE CORRECTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13673715 ↗MalfunctionSep 30, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THAT THE DEVICE TURNED OFF MULTIPLE TIMES DURING OVERNIGHT OXIMETRY TESTING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED AS PART OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12558489 ↗MalfunctionSep 16, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE RAD-97 PROVIDED INACCURATE ETCO2 READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12485387 ↗MalfunctionJul 29, 2021Display or Visual Feedback Problem; Incorrect Measurement; Display or Visual Feedback Problem; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE VALUES AND A CONSTANT BLINKING RED LIGHT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12249793 ↗MalfunctionJul 1, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THAT THE RAD-97 TURNED OFF DURING USE AND WOULD NOT TURN BACK ON. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12100736 ↗MalfunctionJun 15, 2021High Readings; High Readings
THE CUSTOMER REPORTED INACCURATE READINGS ON CAPNOGRAPHY CO2. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12003801 ↗MalfunctionJul 3, 2020Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE IS NOT GETTING ACCURATE ETCO2 READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10227833 ↗MalfunctionJul 3, 2020Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE IS NOT GETTING ACCURATE ETCO2 READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10227767 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.