Rad-97 9738Recalls & reported problems
Masimo Corporation · Rad-97 · Class 2
Quick summary
This Masimo Rad-97 patient monitor has 224 adverse event reports, 222 of which describe malfunctions. No injuries are recorded, and 1 report lists a death. Many reports describe the monitor shutting down or resetting on its own, sensing readings intermittently, or not sounding an alarm when the battery is low. 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
- 222
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 222 adverse event reports that list this exact device (DI 00843997012317), received between Nov 27, 2017 and Sep 25, 2026 — classified as 1 death, 221 malfunctions.
The most frequently reported specific device problem is “Unexpected Shutdown” (67 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
- Unexpected Shutdown67
- Sensing Intermittently43
- Inappropriate or Unexpected Reset33
- No Audible Alarm23
- Incorrect Measurement21
- Defective Alarm11
- Device Alarm System11
- Failure to Power Up6
Patient problems
- No Clinical Signs, Symptoms or Conditions178
- No Consequences Or Impact To Patient42
- Brain Injury1
- Death1
Recent adverse event reports
The 25 most recent of 222 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902565 ↗MalfunctionSep 19, 2026Defective Alarm; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832416 ↗MalfunctionSep 19, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832409 ↗MalfunctionSep 15, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766050 ↗MalfunctionSep 7, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50645066 ↗MalfunctionSep 7, 2026Defective Alarm; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50645063 ↗MalfunctionSep 4, 2026Incorrect Measurement; Sensing Intermittently
The customer reported Intermittently cutting out with replace sensor on a known working setup. Found extra sensitive to interference and giving inaccurate SPO2% readings. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50604258 ↗MalfunctionSep 3, 2026Defective Alarm; Unexpected Shutdown
The customer reported that the device is turning off and on without any error message or alarm. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50578605 ↗MalfunctionSep 3, 2026Sensing Intermittently
The customer reported: "intermittent readings". There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50578538 ↗MalfunctionSep 1, 2026Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50537145 ↗MalfunctionSep 1, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50537143 ↗MalfunctionSep 1, 2026Defective Alarm; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50536089 ↗MalfunctionSep 1, 2026Unexpected Shutdown
The customer reported that the device is turning on and off with no error messages or alarms. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50535909 ↗MalfunctionSep 1, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50535628 ↗MalfunctionAug 25, 2026Unexpected Shutdown
The customer reported that "The power turns off by itself". There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50422927 ↗MalfunctionAug 23, 2026Device Alarm System; No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50393444 ↗MalfunctionAug 23, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50393440 ↗MalfunctionAug 7, 2026Sensing Intermittently
The customer reported "Returned from a patient because the connection between the RAD and the sensor is faulty. The device regularly loses data. Test performed with the M20 Tester; same problem - the RAD has great difficulty receiving data." There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50170081 ↗MalfunctionAug 7, 2026Unexpected Shutdown
The customer reported the device shuts down without any warning. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50170050 ↗DeathJan 12, 2026Accessory Incompatible; Failure to Sense
THE CUSTOMER REPORTED "ON (B)(6) 2025, PROMPT CARE WAS NOTIFIED THAT A PATIENT USING A SUNSET HEALTHCARE SOLUTIONS SPO2 SENSOR WITH THE RAD 97 MASIMO DIED AFTER GOING BRAIN DEAD BECAUSE THE SYSTEM DID NOT ALARM." BASED ON THE MEDICAL DEVICE PROBLEM CODES, IT WAS REPORTED THE ACCESSORY WAS INCOMPATIBLE AND A FAILURE TO SENSE.
Patient problems: Brain Injury
MAUDE report 24031600 ↗MalfunctionDec 1, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THAT THE DEVICE KEEPS TURNING ITSELF OFF AND ON AGAIN. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23689170 ↗MalfunctionNov 11, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE UNIT POWERS OFF BY ITSELF AND IT BECOMES UNUSABLE. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23529208 ↗MalfunctionNov 7, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-97 "SHUT ITSELF OFF SHORTLY AFTER BEGINNING MONITORING." PER ADDITIONAL INFORMATION OBTAINED VIA CONVERSATION WITH THE CUSTOMER "THE DEVICE TURNS OFF BY ITSELF RANDOMLY. SOMETIMES RIGHT AWAY; SOMETIMES NOT." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23503887 ↗MalfunctionNov 6, 2025Device Alarm System; Device Alarm System
THE CUSTOMER REPORTED "NO ALARM". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23493843 ↗MalfunctionOct 31, 2025Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE RAD-97 "CUTS OFF." PER ADDITIONAL INFORMATION FROM THE CUSTOMER, "THE DEVICE STOPPED PROVIDING READINGS DURING TESTING." THERE WAS NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23444160 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.