Nellcor MAXIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884522040942), received between Jan 31, 2024 and Jan 31, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJan 31, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE STUDY SHOWED THAT THE SENSOR WAS NOT ACCURATE AND OVER THE 5% THAT STATES THEIR SENSORS TO BE ACCURATE AT DURING USE WITH A PATIENT. THE STUDY COVERS THE USE OF 3 SENSORS THAT ARE USED TO DETERMINE THE BEST AND ACCURATE SENSOR AT A SPECIFIC SATURATION. THERE WAS 50 PATIENTS WHO WERE NOTED IN THE STUDY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613357 ↗

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.