Rad-5 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
- 76
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Rad-5 Handheld signal extraction pulse oximeter by Masimo Corporation in the FDA's device registry (GUDID). Together they are named in 76 adverse event reports in the FDA's MAUDE database, received between Apr 27, 2017 and May 26, 2026 — classified as 76 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (53 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
Reports received per month, all models
Most reported Rad-5 Handheld signal extraction pulse oximeter problems
Device problems
- Display or Visual Feedback Problem53
- Incorrect Measurement10
- Inappropriate or Unexpected Reset3
- Incorrect, Inadequate or Imprecise Result or Readings2
- No Display/Image2
- Break1
- Defective Alarm1
- Device Alarm System1
Patient problems
- No Consequences Or Impact To Patient62
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient2
Rad-5 Handheld signal extraction pulse oximeter models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 65 reports
- 11 reports
Recent Rad-5 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.
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 ↗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 ↗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 ↗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 ↗
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
- LNCS-II rainbow2 models · 1 reports · 1 recall
- Rad-5v Handheld signal extraction pulse oximeter2 models · 46 reports
- 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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