Nellcor MAXIJRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20884522040881), received between Nov 28, 2019 and Aug 11, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Failure to Analyze Signal” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT DURING USE, THE DEVICE HAD LOW READINGS. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22771054 ↗
• MalfunctionJul 17, 2025Image Display Error/Artifact; Incorrect Measurement; Failure to Analyze Signal; Image Display Error/Artifact; Incorrect Measurement; Failure to Analyze Signal

  IT WAS REPORTED THAT, DURING USE, THE SENSOR DISPLAYED ABNORMAL READINGS, AND SPO2 VALUES WERE NOT SHOWN. THE SENSOR WAS REPLACED EVERY TWO WEEKS, AND AUXILIARY/SUPPORT TAPE WAS APPLIED DURING USE. ERROR 10 OCCURRED, BUT NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531564 ↗
• MalfunctionJul 17, 2025Image Display Error/Artifact; Incorrect Measurement; Failure to Analyze Signal; Image Display Error/Artifact; Incorrect Measurement; Failure to Analyze Signal

  IT WAS REPORTED THAT, DURING USE, THE SENSOR DISPLAYED ABNORMAL READINGS, AND SPO2 VALUES WERE NOT SHOWN. THE SENSOR WAS REPLACED EVERY TWO WEEKS, AND AUXILIARY/SUPPORT TAPE WAS APPLIED DURING USE. ERROR 10 OCCURRED, BUT NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531446 ↗
• MalfunctionJul 17, 2025Image Display Error/Artifact; Incorrect Measurement; Failure to Analyze Signal; Image Display Error/Artifact; Incorrect Measurement; Failure to Analyze Signal

  IT WAS REPORTED THAT, DURING USE, THE SENSOR DISPLAYED ABNORMAL READINGS, AND SPO2 VALUES WERE NOT SHOWN. THE SENSOR WAS REPLACED EVERY TWO WEEKS, AND AUXILIARY/SUPPORT TAPE WAS APPLIED DURING USE. ERROR 10 OCCURRED, BUT NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531430 ↗
• MalfunctionJul 17, 2025Image Display Error/Artifact; Incorrect Measurement; Failure to Analyze Signal; Image Display Error/Artifact; Incorrect Measurement; Failure to Analyze Signal

  IT WAS REPORTED THAT, DURING USE, THE SENSOR DISPLAYED ABNORMAL READINGS, AND SPO2 VALUES WERE NOT SHOWN. THE SENSOR WAS REPLACED EVERY TWO WEEKS, AND AUXILIARY/SUPPORT TAPE WAS APPLIED DURING USE. ERROR 10 OCCURRED, BUT NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531395 ↗
• MalfunctionJul 17, 2025Image Display Error/Artifact; Incorrect Measurement; Failure to Analyze Signal; Image Display Error/Artifact; Incorrect Measurement; Failure to Analyze Signal

  IT WAS REPORTED THAT, DURING USE, THE SENSOR DISPLAYED ABNORMAL READINGS, AND SPO2 VALUES WERE NOT SHOWN. THE SENSOR WAS REPLACED EVERY TWO WEEKS, AND AUXILIARY/SUPPORT TAPE WAS APPLIED DURING USE. ERROR 10 OCCURRED, BUT NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531345 ↗
• MalfunctionOct 6, 2022Temperature Problem; Patient Device Interaction Problem; Temperature Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SENSOR WAS ATTACHED TO THE NEWBORN. THE MEASUREMENT SITE WAS REPLACED APPROXIMATELY 7 HOURS AFTER APPLICATION, SO THE CONDITION OF THE SKIN WAS CHECKED. THE PATIENT EXPERIENCED MILD REDDENING-LIKE SYMPTOMS IN THE RIGHT BACK OF THE HAND. IT WAS DIRECTLY BELOW THE EMITTING PART OF THE SENSOR. THE DEVICE WAS USED AS PER THE PACKAGE INSERT, BUT IT OCCURRED. THE PATIENT'S CIRCULATORY STATUS WAS POOR, AND THE PATIENT WAS IN A CONDITION IN WHICH REDNESS TENDS TO OCCUR, BUT THE EMITTING PART MIGHT HAVE BEEN HOTTER THAN THE STANDARD RANGE. CHECKED THE SITE ABOUT 5 HOURS AFTER THE EVENT OCCURRED, BUT THERE WAS STILL REDNESS AT THAT TIME. IT WAS TREATED WITH MOISTURIZING CREAM AND PATIENT WAS CURRENTLY RECOVERING.

  Patient problems: Inflammation

  MAUDE report 15555803 ↗
• MalfunctionNov 28, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, A SENSOR WAS ATTACHED TO THE LEFT THUMB AND WAS REPLACED ON THE LEFT MIDDLE FINGER. THE PATIENT COMPLAINED OF PAIN THE NEXT DAY AND THE SENSOR WAS ATTACHED TO THE LEFT THUMB. REDNESS WAS FOUND IN THE SENSOR ATTACHED PART OF THE LEFT MIDDLE FINGER WHICH DEVELOPED INTO BLISTER.

  Patient problems: Skin Irritation

  MAUDE report 9390211 ↗

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.