Radius-7 9903Recalls & reported problems
Masimo Corporation · Radius-7 Wearable Pulse CO-Oximeter with Wi-Fi · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00843997014106), received between Aug 6, 2021 and Sep 21, 2023 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Sensing Intermittently” (5 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.
Most reported problems
Device problems
- Sensing Intermittently5
- Loose or Intermittent Connection2
- Defective Alarm1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
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 17794670 ↗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 IS DROPPING OUT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13197239 ↗MalfunctionDec 14, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
THE CUSTOMER REPORTED INTERMITTENT CONNECTION. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13006622 ↗MalfunctionDec 14, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
THE CUSTOMER REPORTED INTERMITTENT CONNECTION. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13006469 ↗MalfunctionAug 6, 2021Defective Alarm; Defective Alarm
THE CUSTOMER REPORTED THAT THE RADIUS-7 DOES NOT ALARM WHEN DISCONNECTED FROM THE ROOT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12289903 ↗
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.