Radius-7 9916Recalls & reported problems
Masimo Corporation · Radius-7 Wearable Pulse CO-Oximeter · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843997014267), received between Jan 7, 2022 and Jun 12, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Sensing Intermittently” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Sensing Intermittently3
- High Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, 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 ↗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 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 ↗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 ↗
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.