Rad-8 Horizontal Signal Extraction Pulse OximeterRecalls & reported problems across all models
Masimo Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 123
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of Rad-8 Horizontal Signal Extraction Pulse Oximeter by Masimo Corporation in the FDA's device registry (GUDID). Together they are named in 123 adverse event reports in the FDA's MAUDE database, received between May 19, 2017 and Dec 13, 2024 — classified as 1 injury, 122 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (61 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-8 Horizontal Signal Extraction Pulse Oximeter problems
Device problems
- Incorrect Measurement61
- Inappropriate or Unexpected Reset27
- No Audible Alarm10
- Device Alarm System6
- Unexpected Shutdown6
- Battery Problem5
- Incorrect, Inadequate or Imprecise Result or Readings4
- Sensing Intermittently4
Patient problems
- No Consequences Or Impact To Patient94
- No Clinical Signs, Symptoms or Conditions26
- No Known Impact Or Consequence To Patient3
- Burn(s)1
Rad-8 Horizontal Signal Extraction Pulse Oximeter models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 122 reports
- 1 report
Recent Rad-8 Horizontal 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.
MalfunctionDec 13, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICES ARE POWERING OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20926304 ↗MalfunctionDec 13, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICES ARE POWERING OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20926299 ↗MalfunctionDec 13, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICES ARE POWERING OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20926283 ↗MalfunctionJul 22, 2024No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THERE WAS "NO SOUND WHEN TESTING WITH THE MASIMO TESTER." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19798572 ↗MalfunctionJul 15, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-8 TURNS OFF AUTOMATICALLY AFTER 10 MINUTES. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19742468 ↗MalfunctionDec 29, 2023Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE RAD-8 DEVICE TURNS OFF BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18420848 ↗MalfunctionOct 24, 2023Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE RAD-8 IS "CUTTING OFF AND NOT TURNING ON AT TIMES". THERE WAS NO PATIENT IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18000288 ↗MalfunctionJun 26, 2023Defective Alarm; Defective Alarm
THE CUSTOMER REPORTED THE DEVICE DID NOT ALARM WHEN IT WAS USED ON A PATIENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17206250 ↗MalfunctionMay 1, 2023Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE RAD-8 PROVIDED INACCURATE VALUES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16850389 ↗MalfunctionApr 3, 2023Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED "THE DEVICE BREAKS OFF DURING THE MEASUREMENT." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16664646 ↗MalfunctionNov 10, 2022No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED A BAD SPEAKER, ALARM DOESN'T SOUND. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15775162 ↗MalfunctionNov 10, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THE DEVICE WAS NOT READING CORRECTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15774372 ↗MalfunctionAug 31, 2022Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE DEVICE TURNS OFF. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15332102 ↗MalfunctionAug 25, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED: "WHEN COMPARED TO OTHER PRODUCTS, SPO2 VALUES WERE DIFFERENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15299186 ↗MalfunctionMar 3, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED "O2 AND HEART READINGS ARE UNSTABLE, WITH GOOD SIGNAL AND PATIENT LOOKS FINE." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13664508 ↗
Other Masimo Corporation products
- RAD-G4 models · 194 reports · 4 recalls
- Rad-973 models · 330 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
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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