RAD-GRecalls & reported problems across all models

We found 4 models of RAD-G by Masimo Corporation in the FDA's device registry (GUDID). Together they are named in 194 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2022 and Sep 29, 2026 — classified as 194 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (153 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

RAD-G recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 15, 2024Open, Classified

   Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

   Z-1539-2024 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

4. Feb 15, 2024Open, Classified

   Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

   Z-1536-2024 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported RAD-G problems

RAD-G models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Rad-G 9849

  Oximeter
  1 recall150 reports
• Rad-G 9847

  Oximeter
  1 recall38 reports
• RAD-G 9895

  Oximeter
  1 recall6 reports
• RAD-G 9210

  Oximeter
  1 recall0 reports

Recent RAD-G adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 24, 2026Application Program Freezes or Fails to Launch

  The customer reported, "The only information we have received is that the touchscreen freezes and doesn't work intermittently, It will be like this for a few minutes and then works again. There was also an issue with the rear casing coming away."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50879903 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗

Other Masimo Corporation products

• Rad-973 models · 330 reports
• Rad-8 Horizontal Signal Extraction Pulse Oximeter2 models · 123 reports
• Radius VSM7 models · 13 reports · 2 recalls
• RD SET12 models · 49 reports · 1 recall
• Rad-5 Handheld signal extraction pulse oximeter2 models · 76 reports
• LNCS-II rainbow2 models · 1 reports · 1 recall
• Rad-5v Handheld signal extraction pulse oximeter2 models · 46 reports
• Radius-73 models · 35 reports