RD SET 4474Recalls & reported problems
Masimo Corporation · RD SET NeoPt CS-2 Adhesive Sensor · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10843997013304), received between Mar 5, 2023 and Mar 4, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Low Readings” (3 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Low Readings3
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Low Readings
THE CUSTOMER REPORTED THAT "THE SPO2 VALUE MEASURED BY MINDRAY/MASIMO WAS "FALSELY" LOW COMPARED WITH FORMER PHILIPS/FAST MONITOR WITH NELLCOR SENSOR AND ABG SAO2: MINDRAY/MASIMO - LEFT HAND: SPO2 = 86; PHILIPS MP2/FAST - FOOT: SPO2 = 94; ABG: SAO2 = 92.4; 4 - 6 PTS DIFFERENCE". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512615 ↗MalfunctionFeb 19, 2026Low Readings
THE CUSTOMER REPORTED THAT "THE SPO2 VALUES MEASURED BY THE MONITOR ARE 'FALSELY' LOW COMPARED WITH THE CLINICAL SIGNS AND BLOOD GAS RESULTS, AND WHEN COMPARED WITH OTHER PULSE OXIMETERS". "THE DELTA OBSERVED COULD VARY FROM 2 TO 15 PTS VERSUS OTHER PULSE OXIMETERS". "THIS HAS LED TO UNNECESSARY OXYGEN TREATMENT" WITH NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24397485 ↗MalfunctionFeb 19, 2026Low Readings
THE CUSTOMER REPORTED THAT "THE SPO2 VALUES MEASURED BY THE MONITOR ARE 'FALSELY' LOW COMPARED WITH THE CLINICAL SIGNS AND BLOOD GAS RESULTS, AND WHEN COMPARED WITH OTHER PULSE OXIMETERS". "THE DELTA OBSERVED COULD VARY FROM 2 TO 15 PTS VERSUS OTHER PULSE OXIMETERS". "THIS HAS LED TO UNNECESSARY OXYGEN TREATMENT" WITH NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24397390 ↗MalfunctionMar 5, 2023Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE SENSOR DISSOLVES AND NO LONGER MEASURES CORRECTLY. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16483499 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.