Rad-97Recalls & reported problems across all models
Masimo Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 330
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of Rad-97 by Masimo Corporation in the FDA's device registry (GUDID). Together they are named in 330 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2017 and Sep 30, 2026 — classified as 1 death, 329 malfunctions.
The most frequently reported specific device problem is “Unexpected Shutdown” (92 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-97 problems
Device problems
- Unexpected Shutdown92
- Sensing Intermittently65
- Inappropriate or Unexpected Reset48
- Incorrect Measurement46
- No Audible Alarm27
- Defective Alarm12
- Device Alarm System12
- Low Readings11
Patient problems
- No Clinical Signs, Symptoms or Conditions262
- No Consequences Or Impact To Patient64
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Brain Injury1
- Bruise/Contusion1
- Death1
- Erythema1
- Pain1
Rad-97 models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Rad-97 9738Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1 death222 reports
- Rad-97 9797Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)85 reports
- Rad-97 9799Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)23 reports
Recent Rad-97 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Audible Alarm; Sensing Intermittently
The customer reported that the device has an audio speaker failure and tb-20 intermittent connection issues. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941662 ↗MalfunctionSep 29, 2026Device Alarm System; Unexpected Shutdown
The customer reported that "after power on the device turn off by itself with no alarm or error message". There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927224 ↗MalfunctionSep 28, 2026Unexpected Shutdown
The customer reported that the device will not power on most of the time. if it does turn on, it shuts off by itself. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910730 ↗MalfunctionSep 25, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902565 ↗MalfunctionSep 24, 2026Sensing Intermittently
The customer reported that the device connects for 2 mins and stops reading. TB20 connection is loose. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877491 ↗MalfunctionSep 19, 2026Defective Alarm; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832416 ↗MalfunctionSep 19, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832409 ↗MalfunctionSep 19, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832405 ↗MalfunctionSep 15, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766050 ↗MalfunctionSep 9, 2026Unexpected Shutdown
The customer reported that when powering on, turns off by itself, and only powers on with the power cord. Per customer, "No error messages are displayed." There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50684702 ↗MalfunctionSep 7, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50645066 ↗MalfunctionSep 7, 2026Defective Alarm; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50645063 ↗MalfunctionSep 4, 2026Incorrect Measurement; Low Readings
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50604926 ↗MalfunctionSep 4, 2026Incorrect Measurement; Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50604842 ↗MalfunctionSep 4, 2026Incorrect Measurement; Sensing Intermittently
The customer reported Intermittently cutting out with replace sensor on a known working setup. Found extra sensitive to interference and giving inaccurate SPO2% readings. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50604258 ↗
Other Masimo Corporation products
- RAD-G4 models · 194 reports · 4 recalls
- 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
- 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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