Rad-5® Handheld signal extraction pulse oximeter 9214Recalls & reported problems
Masimo Corporation · Class 2
All models of Rad-5 Handheld signal extraction pulse oximeter (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00843997005913), received between Feb 15, 2018 and May 26, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Display or Visual Feedback Problem5
- Incorrect, Inadequate or Imprecise Result or Readings2
- Defective Alarm1
- Device Alarm System1
- Incorrect Measurement1
- No Audible Alarm1
- Sensing Intermittently1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient5
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THE RAD-5 WAS PROVIDING "INACCURATE READINGS." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25274240 ↗MalfunctionApr 21, 2026Defective Alarm
THE CUSTOMER REPORTED THE SPEAKER DOES NOT WORK. ADDITIONALLY, THE HOUSING IS DAMAGED. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948369 ↗MalfunctionNov 21, 2025Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE DEVICE IS "HAVING INCORRECT READINGS". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23622034 ↗MalfunctionApr 12, 2024Device Alarm System; Device Alarm System
THE CUSTOMER REPORTED A SPEAKER FAULT. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101893 ↗MalfunctionAug 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Sensing Intermittently; Incorrect, Inadequate or Imprecise Result or Readings; Sensing Intermittently
THE CUSTOMER REPORTED THE RAD-5 WAS "NOT READING SPO2 CORRECTLY" AND "BPM [WAS] NOT ACCURATE." ADDITIONALLY, A "DROPOUT WITH LIMITED MOTION" WAS OBSERVED. THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17559134 ↗MalfunctionFeb 6, 2023No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THE RAD-5 LOUD SPEAKER "NO LONGER EMITS ANY SOUNDS." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16304539 ↗MalfunctionJul 29, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED: "FAILURE ON READING LED - FREEZE AND STILL TURN ON CUSTOMER CAN HAVE THE READING OF VALUE." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7729973 ↗MalfunctionApr 5, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DISPLAY WAS DEFECTIVE DUE TO A MISSING SEGMENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7401708 ↗MalfunctionApr 5, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DISPLAY WAS DEFECTIVE DUE TO A MISSING SEGMENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7401706 ↗MalfunctionMar 2, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED SOME SEGMENTS OF THE LED'S 7-SEGMENT DISPLAY FOR THE SPO2 ARE BLANK. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7311693 ↗MalfunctionFeb 15, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED: "RAD-5 TOP DISPLAY IS MISSING A SEGMENT IN MIDDLE 7-SEGMENT DISPLAY." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275912 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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