RD SET 4479Recalls & reported problems
Masimo Corporation · RD SET NeoPt CS-3 Adhesive Sensor · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10843997013311), received between Feb 14, 2023 and Apr 3, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Low Readings” (2 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.
Most reported problems
Device problems
- Low Readings2
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2023Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16665545 ↗MalfunctionFeb 28, 2023Low Readings; Low Readings
THE CUSTOMER REPORTED THE SENSOR PROVIDED LOW SPO2 READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16456671 ↗MalfunctionFeb 14, 2023Low Readings; Low Readings
THE CUSTOMER REPORTED LOW SPO2 VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16375203 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.