Rad-G 9849Recalls & reported problems
Masimo Corporation · Rad-G, Continuous Pulse Oximeter · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Masimo Rad-G pulse oximeter is a handheld device that monitors blood oxygen. Its 150 adverse event reports include no injuries and no deaths, and most describe the device shutting down unexpectedly or resetting, sometimes with no SpO2 reading. The device has 1 recall, open and begun in February 2024, because it may power off and on by itself, causing a loss of monitoring.
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
- 150
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 00843997000666), received between Dec 9, 2022 and Sep 29, 2026 — classified as 150 malfunctions.
The most frequently reported specific device problem is “Unexpected Shutdown” (127 reports).
1 FDA recall record name this device's 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, 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
Recalls naming this device
- Feb 15, 2024Open, Classified
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Z-1538-2024 · Root cause: Material/Component Contamination · FDA record ↗
Most reported problems
Device problems
- Unexpected Shutdown127
- Inappropriate or Unexpected Reset15
- Sensing Intermittently7
- Device Alarm System3
- Incorrect, Inadequate or Imprecise Result or Readings2
- Defective Alarm1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions148
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Defective Alarm; Sensing Intermittently
The customer reported the customer reports measurement losses. The device did not provide an alarm or displayed an error message. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927234 ↗MalfunctionJun 17, 2026Device Alarm System; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE DEVICE IS NOT RESPONDING WELL¿IT WORKS INTERMITTENTLY, SOMETIMES RESPONDING AND SOMETIMES NOT. THERE WERE NO ALARMS OR ERROR MESSAGES. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25528825 ↗MalfunctionJun 1, 2026Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED WHEN THE RAD-G "IS POWERED ON AND IN USE, BUT SOMETIMES IT SUDDENLY TURNS OFF AND THEN RESTARTS ON ITS OWN. EVEN WHEN IT'S PLUGGED IN, THE CHARGING ICON DOESN'T APPEAR, AND SOMETIMES IT DOESN'T SEEM TO BE CHARGING." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25353039 ↗MalfunctionMay 18, 2026Sensing Intermittently
THE CUSTOMER REPORTED "SOMETIMES SPO2 IS NOT DETECTED" ON THE RAD-97. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25197385 ↗MalfunctionMay 17, 2026Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G WAS "INTERMITTENTLY TURNING ON AND OFF." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196213 ↗MalfunctionApr 18, 2026Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE IS INTERMITTENTLY SWITCHING ITSELF OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24919944 ↗MalfunctionApr 18, 2026Sensing Intermittently
THE CUSTOMER REPORTED THAT "THE SPO2 VALUE IS INTERMITTENTLY NOT DISPLAYED ON THE RAD-G. ALTHOUGH THE LIGHT-EMITTING SECTION IS ILLUMINATED, THE SPO2 VALUE CANNOT BE OBTAINED". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24919040 ↗MalfunctionApr 1, 2026Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE TURNS OFF BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754353 ↗MalfunctionMar 31, 2026Device Alarm System
THE CUSTOMER REPORTED THAT THE RAD-G, CABLES, AND SENSOR ARE "UNRELIABLE" AND CONSTANTLY DISPLAY 'SENSOR OFF PATIENT' ¿PULSE SEARCH' OR 'REPLACE SENSOR' ERROR MESSAGES. PER ADDITIONAL INFORMATION FROM THE CUSTOMER, "ALSO, THERE ARE TIMES WHEN IT DOES NOT ALARM AND I LOOK AT THE SCREEN AND IT IS A FLAT LINE, NO TELLING HOW LONG IT HAS NOT BEEN READING. FOR A CHILD WHO IS MEDICALLY COMPLEX, HAS A TRACHEOSTOMY AND IS MONITORED 24/7 WITH AN UNRELIABLE PULSE OX MACHINE, IT COULD BE DETRIMENTAL TO NOT HAVE ACCURATE AND CONSISTENT READINGS." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750442 ↗MalfunctionMar 2, 2026Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE TURNS OFF EVEN IF IT USES AC ADAPTER. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24477789 ↗MalfunctionMar 2, 2026Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G "POWER[S] OFF BY ITSELF." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24477569 ↗MalfunctionOct 12, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G "ON/OFF SWITCH STICKS" AND THE "DEVICE SWITCHES OFF SUDDENLY." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23273667 ↗MalfunctionAug 19, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-GS "WOULD INTERMITTENTLY TURN THEMSELVES OFF WITHOUT ANYONE TOUCHING IT." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22846638 ↗MalfunctionAug 1, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE "MACHINE JUST SWITCHES OFF TO A BLACK SCREEN AND THEN RANDOMLY TURNS BACK ON AND GOES THROUGH THE STARTUP". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22693119 ↗MalfunctionJul 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Shutdown; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G "IS TURNING ON AND OFF" AND THE "READINGS ARE INACCURATE." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22499928 ↗MalfunctionJun 23, 2025Inappropriate or Unexpected Reset; Unexpected Shutdown; Inappropriate or Unexpected Reset; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G WAS "GETTING ON/OFF AUTOMATICALLY." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309475 ↗MalfunctionJun 9, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE IS "GETTING ON OFF AUTOMATICALLY". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22173071 ↗MalfunctionJun 9, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G "LOSES POWER WHEN MOVED." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22173036 ↗MalfunctionJun 9, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE POWER TURNS OFF WITHOUT PERMISSION WHILE IN USE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22172803 ↗MalfunctionJun 9, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE IS "GETTING ON OFF AUTOMATICALLY". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22172703 ↗MalfunctionJun 9, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G "TURNS OFF BY ITSELF." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22172652 ↗MalfunctionJun 3, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G TURNS OFF BY ITSELF. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22138036 ↗MalfunctionMar 6, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-GS "TURN OFF ON ITS OWN." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21539849 ↗MalfunctionMar 6, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-GS "TURN OFF ON ITS OWN." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21539848 ↗MalfunctionFeb 20, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G "POWERS OFF ON ITS OWN." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21428350 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.