Nellcor OXI-P/IRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884522042823), received between Jan 31, 2024 and Jan 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Readings” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K012891); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Incorrect Measurement; High Readings; Low Readings; Incorrect Measurement; High Readings; Low Readings

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE USE, THE SENSOR EXHIBITED HIGH, LOW, ERRATIC, AND INACCURATE READINGS, WITH READINGS DROPPING OFF TO FLATLINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143536 ↗
• MalfunctionNov 7, 2024Image Display Error/Artifact; Low Readings; Image Display Error/Artifact; Low Readings

  ACCORDING TO THE REPORTER, THE OXIMETER PROBE SITS BEDSIDE NO DIRECT SUNLIGHT AND HAS BEEN WORKING FINE UNTIL ABOUT 2 DAYS AGO. IT WAS FAILING EVEN WHEN BASELINE WAS NORMAL, GIVING A LOW SPO2 READING AND PROVIDING AN ERROR CODE. THE DEVICE HAD TO REVERT TO USING DISPOSABLE PROBES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20627216 ↗
• MalfunctionJan 31, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, USED A DIFFERENT MONITOR ON THE PATIENT AND THE READINGS FROM THE SENSORS WERE SHOWED 5 LOWER THAN OTHER SENSORS AND MONITORS. ANOTHER SENSOR WERE USED AND ABLE TO GET THE ACCURATE READINGS ON THE NURSE. THE ISSUE WAS ISOLATED TO THE SENSOR. THERE WAS NO ADVERSE EFFECT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613790 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012891. One submission often covers many models, so check the product and lot details in each record.

• Z-0664-05 · Oct 18, 2004 · Terminated
  Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.