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RD rainbow SET-2 4028Recalls & reported problems

Masimo Corporation · RD rainbow SET-2 Infant Pulse CO-Oximeter Adhesive Sensor · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10843997010921), received between Jun 28, 2019 and Jun 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Readings” (1 report).

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

  • High Readings1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 28, 2019High Readings; High Readings

    THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED HIGH READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8746439 ↗

Other Oximeter devices

All Oximeter devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.