Radius-7Recalls & reported problems across all models

We found 3 models of Radius-7 by Masimo Corporation in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Nov 21, 2017 and Jun 12, 2026 — classified as 1 death, 34 malfunctions.

The most frequently reported specific device problem is “Sensing Intermittently” (15 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. 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

Most reported Radius-7 problems

Radius-7 models

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

• Radius-7 9664

  Oximeter
  1 death23 reports
• Radius-7 9903

  Oximeter
  8 reports
• Radius-7 9916

  Oximeter
  4 reports

Recent Radius-7 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026High Readings

  THE CUSTOMER REPORTED THE RADICAL-7 AND RADIUS VSM WERE "READING HIGHER THAN SECONDARY PULSE OXIMETER USED AND SEEMS TO BE OVER READING. PATIENTS WHO HAVE KNOWN DESATURATIONS (DUE TO PULMONARY FIBROSIS), REMAIN WITHIN NORMAL LIMITS ON MASIMO, HOWEVER DESATURATION NOTED ON OTHER DEVICES." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482167 ↗
• MalfunctionJan 19, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THE RADIUS-7 SHUTS DOWN. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18547471 ↗
• MalfunctionSep 21, 2023Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE RADIUS-7 MODULE "INTERMITTENTLY CUTS OUT."  THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795170 ↗
• MalfunctionSep 21, 2023Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE RADIUS-7 MODULE "INTERMITTENTLY CUTS OUT." THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17794959 ↗
• MalfunctionSep 21, 2023Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE RADIUS-7 MODULE "INTERMITTENTLY CUTS OUT." THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17794670 ↗
• MalfunctionSep 20, 2023Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE RADIUS-7 MODULE "LOSES CONNECTION WHEN JOSTLED." THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786451 ↗
• MalfunctionJul 21, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THE DEVICE SHUTS OFF AFTER 10 MINUTES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080272 ↗
• MalfunctionApr 19, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THE MONITOR DISPLAY WAS FROZEN. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14149412 ↗
• MalfunctionApr 19, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THE MONITOR DISPLAY WAS FROZEN. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14149383 ↗
• MalfunctionApr 19, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THE MONITOR DISPLAY WAS FROZEN. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14149344 ↗
• MalfunctionApr 15, 2022Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE VITALS DROP OUT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14123270 ↗
• MalfunctionMar 4, 2022Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE DEVICE STOPS READING AFTER A LITTLE BIT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13676186 ↗
• MalfunctionJan 7, 2022Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE DEVICE WAS INTERMITTENT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13197658 ↗
• MalfunctionJan 7, 2022Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE DEVICE IS DROPPING OUT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13197239 ↗
• MalfunctionJan 4, 2022Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE MODULE WORKS INTERMITTENTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155652 ↗

Other Masimo Corporation products

• RAD-G4 models · 194 reports · 4 recalls
• 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