EMMA KitRecalls & 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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of EMMA Kit by Masimo Corporation in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2022 and Jun 14, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Low Readings” (8 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 EMMA Kit problems
Device problems
- Low Readings8
- Unexpected Shutdown8
- High Readings7
- Incorrect Measurement2
- Defective Alarm1
- Device Alarm System1
- Inappropriate or Unexpected Reset1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
EMMA Kit models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EMMA™ Kit 3639Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase24 reports
- 3 reports
Recent EMMA Kit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2026Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THE DEVICE HAS "ERRATIC READINGS". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25496864 ↗MalfunctionMar 16, 2026High Readings
THE CUSTOMER REPORTED THE EMMAS WERE PROVIDING "INACCURATE READINGS" AS THE EMMAS WERE "GETTING HIGHER READINGS IN COMPARISON TO THEIR OTHER END TIDAL CO2 DEVICE." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24612629 ↗MalfunctionMar 14, 2026High Readings
THE CUSTOMER REPORTED THE EMMAS WERE PROVIDING "INACCURATE READINGS" AS THE EMMAS WERE "GETTING HIGHER READINGS IN COMPARISON TO THEIR OTHER END TIDAL CO2 DEVICE." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24601455 ↗MalfunctionFeb 18, 2026Low Readings
THE CUSTOMER REPORTED THE EMMA WAS "CONSISTENTLY GETTING A LOW READING" AS THE MEASUREMENTS WERE "USUALLY 5-8 UNDER EVEN AFTER PERFORMING ZEROING." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24384718 ↗MalfunctionFeb 17, 2026Low Readings
THE CUSTOMER REPORTED THE EMMA WAS "CONSISTENTLY GETTING A LOW READING" AS THE MEASUREMENTS WERE "USUALLY 5-8 UNDER EVEN AFTER PERFORMING ZEROING." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24373918 ↗MalfunctionDec 30, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE IS POWERING OFF BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23931633 ↗MalfunctionDec 30, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE POWER[ED] OFF BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23931627 ↗MalfunctionDec 27, 2025Device Alarm System; Unexpected Shutdown; Device Alarm System; Unexpected Shutdown
THE CUSTOMER REPORTED THE EMMA "WOULD KEEP TURNING ITSELF OFF AFTER A FEW MINUTES." PER ADDITIONAL INFORMATION FROM THE CUSTOMER, NO ALARMS WERE PROVIDED. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23901426 ↗MalfunctionNov 11, 2025High Readings; High Readings
THE CUSTOMER REPORTED THAT THE ETCO2 READINGS WERE HIGHER THAN EXPECTED. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23528808 ↗MalfunctionNov 5, 2025Low Readings; Low Readings
THE CUSTOMER REPORTED THAT THE DEVICE ETCO2 READINGS WERE LOWER THAN EXPECTED, NO ALARMS OR ERROR MESSAGES WERE PRESENT ON THE DEVICE. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23482763 ↗MalfunctionSep 16, 2025Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED OBTAINING "HIGH ETCO2 LEVELS" WITH THE EMMA AS THE ETCO2 READINGS WERE "CONSISTENTLY HIGHER THAN 65," HOWEVER A BLOOD GAS DRAW PROVIDED A CO2 VALUE OF 52. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23069770 ↗MalfunctionAug 26, 2025Incorrect Measurement; Low Readings; Incorrect Measurement; Low Readings
THE CUSTOMER REPORTED THAT THE DEVICE READING[S] ARE INACCURATE; THE VALUES WERE SIGNIFICANTLY LOWER AS WELL AS INCONSISTENT. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22901132 ↗MalfunctionMay 22, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE "POWER TURNS OFF WHILE USING IT (EVEN AFTER CHANGING THE BATTERY), POOR AIRWAY ADAPTER RECOGNITION." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22073971 ↗MalfunctionJul 23, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE EMMA "TURNS OFF EVEN WHEN REPLACED WITH FULL CHARGE BATTERIES." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19812494 ↗MalfunctionJun 7, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE EMMA "SHUTS OFF" DURING MONITORING. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19487072 ↗
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
- Rad-5v Handheld signal extraction pulse oximeter2 models · 46 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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