Rad-G 9847Recalls & reported problems
Masimo Corporation · Rad-G 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 measures blood oxygen levels. Reports mostly describe the device unexpectedly shutting off or restarting, with some reports of intermittent readings, inaccurate results, and display or alarm problems. There are 41 reports, with no deaths or injuries. One open recall, started in February 2024, concerns the oximeter powering off and on and interrupting monitoring. Reports increased from 5 in the previous 12 months to 16 in the latest 12 months.
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
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00843997013284), received between Jul 20, 2022 and May 3, 2026 — classified as 38 malfunctions.
The most frequently reported specific device problem is “Unexpected Shutdown” (21 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-1537-2024 · Root cause: Material/Component Contamination · FDA record ↗
Most reported problems
Device problems
- Unexpected Shutdown21
- Inappropriate or Unexpected Reset7
- Sensing Intermittently6
- Incorrect, Inadequate or Imprecise Result or Readings3
- Device Alarm System2
- Incorrect Measurement1
- Low Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THE RAD-G WAS PROVIDING "INACCURATE READINGS." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25063819 ↗MalfunctionMay 3, 2026Sensing Intermittently
THE CUSTOMER REPORTED THAT THE DEVICE SUDDENLY STOPPED MEASURING DURING USE, AND REPLACING THE PROBE AND SENSOR CABLE DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25063771 ↗MalfunctionMar 20, 2026Device Alarm System
THE CUSTOMER REPORTED THAT THE DEVICE "WON'T ALARM WHEN SENSOR IS OFF". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24656425 ↗MalfunctionMar 16, 2026Sensing Intermittently
THE CUSTOMER REPORTED THAT THE SPO2 READING IS DISPLAYED INTERMITTENTLY AND DOES NOT REMAIN STABLE. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24613991 ↗MalfunctionMar 14, 2026Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE RANDOMLY POWERS OFF BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24601458 ↗MalfunctionMar 3, 2026Sensing Intermittently; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDES INTERMITTENT READINGS & POWER'S ON AND OFF BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24493577 ↗MalfunctionFeb 10, 2026Unexpected Shutdown
THE CUSTOMER REPORTED "THE POWER TURNS ITSELF ON AND OFF". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24310740 ↗MalfunctionFeb 9, 2026Sensing Intermittently
THE CUSTOMER REPORTED THE RAD-G "WILL WORK INTERMITTENTLY, WITH A GOOD TRACE BUT IT WILL DROP OUT FOR NO REASON, THE LINES ARE FLAT AND IT WILL BE VERY DIFFICULT TO GET A GOOD TRACE AGAIN." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24300757 ↗MalfunctionDec 30, 2025Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED MEASUREMENTS ON THE RAD-G "STOPPED WORKING." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23931583 ↗MalfunctionDec 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Shutdown; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE IS MALFUNCTIONING. THE SENSOR IS NOT DETECTING ACCURATELY, AND THE SCREEN INTERMITTENTLY GOES BLACK AND POWERS OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23785867 ↗MalfunctionDec 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE RAD-G "CONSTANTLY DISPLAYS INCORRECT VALUES EVEN AFTER SENSOR REPLACEMENT." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23785721 ↗MalfunctionNov 15, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G "TURNS ON AND OFF CONSTANTLY AND CANNOT PERFORM ITS CORRECT FUNCTIONS." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563531 ↗MalfunctionNov 3, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THAT THE DEVICE TURNS ON AND OFF AUTOMATICALLY. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23460258 ↗MalfunctionOct 21, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G "POWERED [OFF] BY ITSELF." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23353914 ↗MalfunctionJan 31, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G WAS "AUTOMATICALLY TURNING ON AND OFF." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21287566 ↗MalfunctionJan 27, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G WAS TURNING ON/OFF BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21243223 ↗MalfunctionJan 16, 2025Device Alarm System; Device Alarm System
THE CUSTOMER REPORTED THE RAD-G "WON'T ALARM WHEN OUTSIDE OF PARAMETERS." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21174914 ↗MalfunctionDec 10, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G "SWITCHES OFF SPORADICALLY." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20894151 ↗MalfunctionOct 29, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE TURNS OFF AND ON BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20558183 ↗MalfunctionOct 25, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE IS INTERMITTENTLY TURNING ON AND OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539513 ↗MalfunctionOct 17, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE EQUIPMENT SWITCHES ON AND OFF AUTOMATICALLY. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20477417 ↗MalfunctionOct 17, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED "UNITS SWITCHING ON/OFF". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20477283 ↗MalfunctionAug 6, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE RAD-G DOES NOT STAY ON CONTINUOUSLY. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19922341 ↗MalfunctionApr 16, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-G DEVICE POWERS ON AND OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19121672 ↗MalfunctionSep 20, 2023Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER STATED THE DEVICE POWERS ON AND OFF BY ITSELF. THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17786449 ↗
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.