Rad-5v™ Handheld signal extraction pulse oximeter 9197Recalls & reported problems

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

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

Quick summary

This is a Masimo Rad-5v handheld pulse oximeter, a small clip-on device that measures blood oxygen levels. The 45 reports mostly describe display problems — digits or LED segments missing or not lighting up, sometimes along with a cracked case — and a couple mention incorrect readings. No deaths 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: 45
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00843997005524), received between Jun 28, 2017 and Feb 11, 2022 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (42 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.

Most reported problems

Device problems

Display or Visual Feedback Problem42
Incorrect Measurement2
Image Display Error/Artifact1

Patient problems

No Consequences Or Impact To Patient44
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 11, 2022Image Display Error/Artifact; Image Display Error/Artifact
THE CUSTOMER REPORTED THE DEVICE HAS DIGITS MISSING FROM THE DISPLAY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13518701 ↗
MalfunctionFeb 11, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DEVICE DISPLAY SHOWS INCORRECT VALUES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11316059 ↗
MalfunctionFeb 3, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DEVICE DOESN'T DISPLAY MEASUREMENTS CORRECTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11276443 ↗
MalfunctionOct 30, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED SOME LEDS ARE NOT ILLUMINATING ON THE DISPLAY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10764224 ↗
MalfunctionAug 26, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE UNIT SHOWS WRONG VALUES IN DISPLAY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10457094 ↗
MalfunctionAug 20, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DISPLAY HAS LED SEGMENTS THAT DO NOT ILLUMINATE AND THE CASE IS CRACKED. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10431498 ↗
MalfunctionJul 8, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED A SEGMENT IN THE DISPLAY IS MISSING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10248096 ↗
MalfunctionApr 15, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE RAD-5V DEVICE HAS MISSING SEGMENTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9965377 ↗
MalfunctionNov 8, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DIGITAL DISPLAY IS DEFECTIVE. THE VALUES IN THE UPPER PART ARE NOT DISPLAYED COMPLETELY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9301391 ↗
MalfunctionNov 1, 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 9268908 ↗
MalfunctionOct 11, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DEVICE IS HAVING A DISPLAY ISSUE AND NOT WORKING PROPERLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9182658 ↗
MalfunctionAug 8, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DEVICE IS MISSING THE FIRST TWO SEGMENTS IN THE TOP AND BOTTOM DISPLAY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8876259 ↗
MalfunctionJun 14, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THE DISPLAY HAD A MISSING SEGMENT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8701806 ↗
MalfunctionApr 23, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DISPLAY IS GOING OUT WITH MISSING SEGMENT LINES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8539891 ↗
MalfunctionMar 13, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DISPLAY IS MISSING A SEGMENT IN THE BPM AREA. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8418094 ↗
MalfunctionJan 11, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DEVICE DISPLAY IS MISSING SOME PIXELS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8241060 ↗
MalfunctionJan 8, 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 8229912 ↗
MalfunctionDec 12, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE RAD-5V DISPLAY FLICKERS AND PART OF THE LED DISPLAY DOES NOT ILLUMINATE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8158380 ↗
MalfunctionNov 2, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DEVICE IS MISSING AN LED SEGMENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8034060 ↗
MalfunctionSep 29, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THE SEGMENTS FOR SPO2 AND PR ARE SOMETIMES MISSING.NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7921231 ↗
MalfunctionSep 27, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT A SEGMENT WAS MISSING FROM THE DISPLAY. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7916349 ↗
MalfunctionAug 12, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED ONE OF THE LED BARS FOR BPM IS MISSING. NO IMPACT OR CONSEQUENCES TO PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7775647 ↗
MalfunctionJun 9, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED MISSING LED SEGMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7585398 ↗
MalfunctionMay 13, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE DIGITS ON THE RAD-5V WERE UNABLE TO ILLUMINATE DURING USE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7509758 ↗
MalfunctionMar 29, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED 1 LED SEGMENT IS BROKEN ON THE DISPLAY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7384400 ↗

Device details

UDI-DI	`00843997005524`
Brand	Rad-5v™ Handheld signal extraction pulse oximeter
Model	9197
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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