Rad-8 Horizontal Signal Extraction Pulse Oximeter 9190Recalls & reported problems
Masimo Corporation · Class 2
All models of Rad-8 Horizontal Signal Extraction Pulse Oximeter (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Masimo Rad pulse oximeter has 122 adverse event reports, with no deaths and 1 injury. Most reports describe incorrect readings, unexpected resets or shutdowns, and missing alarm sounds, and most note no patient impact. 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
- 122
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 00843997005647), received between May 19, 2017 and Dec 13, 2024 — classified as 1 injury, 121 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (61 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. 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
- Incorrect Measurement61
- Inappropriate or Unexpected Reset27
- No Audible Alarm10
- Device Alarm System6
- Battery Problem5
- Unexpected Shutdown5
- Incorrect, Inadequate or Imprecise Result or Readings4
- Sensing Intermittently4
Patient problems
- No Consequences Or Impact To Patient94
- No Clinical Signs, Symptoms or Conditions25
- No Known Impact Or Consequence To Patient3
- Burn(s)1
Recent adverse event reports
The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICES ARE POWERING OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20926299 ↗MalfunctionDec 13, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICES ARE POWERING OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20926283 ↗MalfunctionJul 22, 2024No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THERE WAS "NO SOUND WHEN TESTING WITH THE MASIMO TESTER." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19798572 ↗MalfunctionJul 15, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-8 TURNS OFF AUTOMATICALLY AFTER 10 MINUTES. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19742468 ↗MalfunctionDec 29, 2023Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE RAD-8 DEVICE TURNS OFF BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18420848 ↗MalfunctionOct 24, 2023Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE RAD-8 IS "CUTTING OFF AND NOT TURNING ON AT TIMES". THERE WAS NO PATIENT IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18000288 ↗MalfunctionJun 26, 2023Defective Alarm; Defective Alarm
THE CUSTOMER REPORTED THE DEVICE DID NOT ALARM WHEN IT WAS USED ON A PATIENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17206250 ↗MalfunctionMay 1, 2023Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE RAD-8 PROVIDED INACCURATE VALUES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16850389 ↗MalfunctionApr 3, 2023Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED "THE DEVICE BREAKS OFF DURING THE MEASUREMENT." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16664646 ↗MalfunctionNov 10, 2022No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED A BAD SPEAKER, ALARM DOESN'T SOUND. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15775162 ↗MalfunctionNov 10, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THE DEVICE WAS NOT READING CORRECTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15774372 ↗MalfunctionAug 31, 2022Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE DEVICE TURNS OFF. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15332102 ↗MalfunctionAug 25, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED: "WHEN COMPARED TO OTHER PRODUCTS, SPO2 VALUES WERE DIFFERENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15299186 ↗MalfunctionMar 3, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED "O2 AND HEART READINGS ARE UNSTABLE, WITH GOOD SIGNAL AND PATIENT LOOKS FINE." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13664508 ↗MalfunctionJan 28, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THE DEVICE POWERS OFF BY ITSELF. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13389546 ↗MalfunctionJan 4, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED UNIT DOES NOT ACCURATELY PROVIDE MEASUREMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13155633 ↗MalfunctionOct 28, 2021Device Alarm System; Device Alarm System
THE CUSTOMER REPORTED THE DEVICE IS NOT ALARMING. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12716328 ↗MalfunctionOct 28, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE IS NOT READING PULSES CORRECTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12716273 ↗MalfunctionOct 19, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED UNIT DOES NOT ACCURATELY PROVIDE MEASUREMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12659082 ↗MalfunctionAug 27, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THE DEVICE SWITCHES OFF WITHOUT ALARMING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12378496 ↗MalfunctionAug 13, 2021Failure to Power Up; Inappropriate or Unexpected Reset; Failure to Power Up; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THE DEVICE IS HARD TO TURN ON, SHUTS OFF RANDOMLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12319428 ↗MalfunctionJun 9, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE SHOWS EXTREMELY DIFFERENT VALUES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11971157 ↗MalfunctionApr 30, 2021Unable to Obtain Readings; Sensing Intermittently; Unable to Obtain Readings; Sensing Intermittently
THE CUSTOMER REPORTED NOT GETTING A STEADY SIGNAL OR ANY SIGNAL AT ALL, NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11752468 ↗MalfunctionMar 19, 2021Device Alarm System; Device Alarm System
THE CUSTOMER REPORTED THE RAD-8 DOES NOT ALARM WHEN ON NURSE CALL. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11527301 ↗MalfunctionFeb 19, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THE UNIT WON'T STAY ON. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11350920 ↗
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
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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