Rad-5v Handheld signal extraction pulse oximeterRecalls & reported problems across all models
Masimo Corporation · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Rad-5v Handheld signal extraction pulse oximeter by Masimo Corporation in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2017 and Feb 11, 2022 — classified as 46 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Rad-5v Handheld signal extraction pulse oximeter problems
Device problems
- Display or Visual Feedback Problem42
- Incorrect Measurement2
- Image Display Error/Artifact1
- Low Readings1
Patient problems
- No Consequences Or Impact To Patient45
- No Clinical Signs, Symptoms or Conditions1
Rad-5v Handheld signal extraction pulse oximeter models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 45 reports
- 1 report
Recent Rad-5v Handheld signal extraction pulse oximeter adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Masimo Corporation products
- RAD-G4 models · 194 reports · 4 recalls
- Rad-973 models · 330 reports
- Rad-8 Horizontal Signal Extraction Pulse Oximeter2 models · 123 reports
- Radius VSM7 models · 13 reports · 2 recalls
- RD SET12 models · 49 reports · 1 recall
- Rad-5 Handheld signal extraction pulse oximeter2 models · 76 reports
- LNCS-II rainbow2 models · 1 reports · 1 recall
- Radius-73 models · 35 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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