Radius-7 9664Recalls & reported problems
Masimo Corporation · Radius-7 Wearable Pulse CO-Oximeter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Masimo Radius-7 is a wearable pulse CO-oximeter that monitors oxygen and related blood levels. The 23 reports naming it mostly describe the device sensing intermittently, losing its connection, freezing displays, or shutting down unexpectedly; most reported no harm to the patient, though one report involved a death and no injuries were reported. No recalls name this device.
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
- 23
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00843997009249), received between Nov 21, 2017 and Jan 19, 2024 — classified as 1 death, 22 malfunctions.
The most frequently reported specific device problem is “Sensing Intermittently” (7 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 Intermittently7
- Loose or Intermittent Connection5
- Display or Visual Feedback Problem3
- Inappropriate or Unexpected Reset2
- Incorrect Measurement2
- Unexpected Shutdown2
- Disconnection1
- No Audible Alarm1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient8
- Death1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗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 13006418 ↗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 13006379 ↗MalfunctionDec 8, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE IS INTERMITTENTLY DISCONNECTING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12965030 ↗MalfunctionJun 24, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
THE CUSTOMER REPORTED THE RADIUS-7 INTERMITTENTLY DISCONNECTS FROM THE MODULE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12063152 ↗MalfunctionJun 10, 2021Disconnection; Disconnection
THE CUSTOMER REPORTED THE DEVICE GLITCHES AND PERIODICALLY DISCONNECTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11975359 ↗MalfunctionApr 9, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
THE CUSTOMER REPORTED THE DEVICE LOSES CONNECTION WITH BOARD. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11641171 ↗MalfunctionApr 1, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THAT THE DEVICE SHUTS DOWN INTERMITTENTLY. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11603076 ↗MalfunctionApr 1, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THAT THE DEVICE SHUTS DOWN INTERMITTENTLY. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11603068 ↗MalfunctionMar 4, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11414223 ↗MalfunctionJan 8, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE WILL NOT HOLD A SIGNAL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11140548 ↗MalfunctionJan 8, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE WILL NOT HOLD A SIGNAL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11140530 ↗MalfunctionMay 11, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE DEVICE WAS INTERMITTENTLY DISCONNECTS SPO2. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10043683 ↗MalfunctionOct 7, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
THE CUSTOMER REPORTED DROPPED CONNECTION WHEN SLIGHTLY MOVED. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9162339 ↗MalfunctionMay 22, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED INTERMITTENT OPERATION OF THE RADIUS-7 MODULE WHEN THE SENSOR IS PLUGGED IN. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8634668 ↗MalfunctionApr 23, 2018Unable to Obtain Readings; Sensing Intermittently; Unable to Obtain Readings; Sensing Intermittently
THE CUSTOMER REPORTED THEY STARTED THE TEST AND IN A FEW SECONDS THE DEVICE STOPPED GIVING A READING, THE PULSE CURVE DRASTICALLY DROPPED, AS DID THE SPO2 CURVE AND IP. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7449930 ↗DeathJan 19, 2018No Audible Alarm; No Audible Alarm
IT WAS REPORTED: "NURSING STAFF AND A PHYSICIAN WERE PRESENT AT THE PATIENT BEDSIDE WHEN THE PATIENT WAS FOUND WITHOUT A PULSE. THE TELEMETRY TECH FROM PCU CALLED TO SAY THE PATIENT WAS IN ASYSTOLE AT THAT TIME. A RAPID RESPONSE WAS ALREADY UNDERWAY. STAFF STATED THE MONITOR DID NOT ALARM IN THE ROOM NOR WAS THE STAFF PAGER INITIATED." PER THE CUSTOMER, THE PATIENT WAS TRANSFERRED TO THE ICU AS THE SAFETYNET SYSTEM AND BEDSIDE MONITORS FAILED TO NOTIFIY CLINICIANS REGARDING THE PATIENT CONDITION. THE PATIENT PASSED AWAY IN THE ICU.
Patient problems: Death
MAUDE report 7208569 ↗MalfunctionNov 21, 2017Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED: ¿SPO2 WAS OFF WHEN COMPARED TO A RAD 5V BY AROUND 10-15%. RADIUS 7 DISCONNECT AS WELL" NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7050882 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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