Rad-5® Handheld signal extraction pulse oximeter 9196Recalls & reported problems

All models of Rad-5 Handheld signal extraction pulse oximeter (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This is a Masimo Rad-5 handheld pulse oximeter, a small clip-on device that measures blood oxygen and pulse rate. The 65 reports mostly describe display and reading problems: screens flickering or going dark, unexpected shutdowns, and readings that seemed wrong or unusually low. No deaths and no injuries were reported, and most reports describe no effect on the patient. 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: 65
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00843997005517), received between Apr 27, 2017 and Oct 23, 2025 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (48 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Display or Visual Feedback Problem48
Incorrect Measurement9
Inappropriate or Unexpected Reset3
No Display/Image2
Break1
Image Display Error/Artifact1
Low Readings1
Unable to Obtain Readings1

Patient problems

No Consequences Or Impact To Patient57
No Clinical Signs, Symptoms or Conditions6
No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 23, 2025Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDES "INACCURATE [SPO2] READINGS". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23376129 ↗
MalfunctionDec 30, 2022Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE SCREEN FLICKERS AND POWER DROPS OUT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16078133 ↗
MalfunctionAug 20, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE PROVIDED INACCURATE PULSE RATE VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15263127 ↗
MalfunctionDec 17, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DEVICE LED DISPLAY COULD NOT BE LIT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13029825 ↗
MalfunctionJul 27, 2021Low Readings; Low Readings
THE CUSTOMER REPORTED THE DEVICE HAS DAMAGE TO THE FRONT CASE AND SHOWS LOW READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12235319 ↗
MalfunctionMar 19, 2021Incorrect Measurement; Unable to Obtain Readings; Incorrect Measurement; Unable to Obtain Readings
THE CUSTOMER REPORTED THE RAD-5 IS NOT MONITORING CORRECTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11527783 ↗
MalfunctionFeb 18, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE SHOWS WRONG VALUES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11345660 ↗
MalfunctionJan 28, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THE DEVICE TURNED OFF OVER NIGHT AND FELT WARMER THAN USUAL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11244783 ↗
MalfunctionDec 18, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DEVICE DISPLAY IS INCORRECT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11038270 ↗
MalfunctionAug 14, 2020Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10408004 ↗
MalfunctionJul 28, 2020Image Display Error/Artifact; Image Display Error/Artifact
THE CUSTOMER REPORTED THAT THE DISPLAY FREEZES DURING MEASUREMENT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10335284 ↗
MalfunctionJun 9, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE RAD-5 DEVICE IS MISSING SEGMENTS IN THE DISPLAY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10136347 ↗
MalfunctionMay 26, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THE RAD-5 POWERED OFF SUDDENLY. THE DEVICE WAS HOT AND WAS UNABLE TO POWER ON. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10088161 ↗
MalfunctionMay 5, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THE DEVICE HAD MISSING LED SEGMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10025124 ↗
MalfunctionMay 1, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THE DEVICE HAD MISSING LED SEGMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10017920 ↗
MalfunctionNov 1, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE MIDDLE 7-SEGMENT DISPLAY (TOP AND BOTTOM) OFTEN FAIL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9269608 ↗
MalfunctionNov 1, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE RAD-5 DEVICE HAS MISSING DISPLAY SEGMENTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9269606 ↗
MalfunctionSep 20, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DEVICE DISPLAY IS MISSING SEGMENT LINES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9101323 ↗
MalfunctionSep 20, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE TOP SEGMENT LINE IS NOT DISPLAYING READING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9099367 ↗
MalfunctionSep 3, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED A SEGMENT LINE IS MISSING ON THE DISPLAY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8955894 ↗
MalfunctionAug 1, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED A DEAD SEGMENT ON THE UPPER DISPLAY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8852421 ↗
MalfunctionApr 11, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED SEGMENT FAILURES ON THE DISPLAY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8505152 ↗
MalfunctionMar 12, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DEVICE DISPLAY IS MISSING SEGMENTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8414979 ↗
MalfunctionMar 6, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE TOP OF THE DISPLAY IS MISSING SEGMENT LINES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8396372 ↗
MalfunctionFeb 17, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DISPLAY IS MISSING SEGMENT LINES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8346496 ↗

Device details

UDI-DI	`00843997005517`
Brand	Rad-5® Handheld signal extraction pulse oximeter
Model	9196
Company	Masimo Corporation
Product code	DQA · Oximeter
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 30, 2018

Device type (GMDN): Pulse Co-oximeter

A portable, battery-powered, electronic device designed to detect hypoxia (oxygen deficiency at the tissue level) via the transcutaneous multiwave measurement and display of carboxy-haemoglobin saturation (SpCO) and typically other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), and haemoglobin concentration (SpHb); pulse rate and haematocrit may also be calculated. A light-emitting diode (LED) and a receiving detector in a probe applied to a body site (e.g., a fingertip) are used to make multiwave measurements using spectrophotometry. The device is used in healthcare settings or the home, often to evaluate carbon monoxide poisoning.

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All Oximeter devices →

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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