Nellcor MAXAJRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20884522040096), received between Mar 22, 2018 and Jan 31, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Low Readings” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SPO2 VALUE WAS DISPLAYED LOW (96%) AND REPLACED WITH A NEW DEVICE AND READINGS IN CREASED TO 100%. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619648 ↗
• MalfunctionSep 27, 2021Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE PRODUCT'S SPO2 MEASUREMENT VALUE WAS LOW DURING A PROCEDURE. THE READING DISPLAYED WAS 96. THE READING INCREASED TO 99 WHEN THE PRODUCT WAS REPLACED.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533021 ↗
• MalfunctionSep 27, 2021Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE PRODUCT'S SPO2 MEASUREMENT VALUE WAS LOW DURING A PROCEDURE. THE READING DISPLAYED WAS AS LOW AS 93 AND THERE WAS DESATURATION. THERE WAS NO PATIENT HARM.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532981 ↗
• MalfunctionJan 5, 2021Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD LOW SPO2 READING. THE EVENT WAS FOUND WHILE TESTING THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11116152 ↗
• MalfunctionDec 9, 2020Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE SPO2 WAS 99% TO 100% AT THE TIME OF COMING IN THE ROOM. THERE WAS A DECREASE IN SPO2 TO 92% - 90% AFTER THE INTRODUCTION OF GENERAL ANESTHESIA, AND THERE WAS NO PROBLEM WITH VENTILATION, SO, INTUBATION WAS PERFORMED. THERE WAS NO INCREASE IN READING EVEN AFTER THE INTUBATION, SO THEY CHANGED TO A NEW ONE, AND THE READING BECAME 100%.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 10977709 ↗
• MalfunctionSep 11, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, INCORRECT SPO2 READINGS WERE PROVIDED. THE READINGS PROVIDED WERE LOWER THAN EXPECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8992560 ↗
• MalfunctionApr 8, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, WHILE IN USE, THE UNIT'S SPO2 READINGS DROPPED TO ABOUT 80%. IT WAS REPORTED THAT THERE MIGHT BE PROBLEM WITH THE SENSOR. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8491545 ↗
• MalfunctionNov 19, 2018High Readings; High Readings

  ACCORDING TO THE REPORTER, THE OXYGEN SATURATION (SPO2) VALUE DISPLAYED REMAIN 100%, BUT THE STATUS OF THE PATIENT WAS BAD. IT WAS STATED THAT THE SENSOR WAS REPLACED AND THE VALUE STARTED TO CHANGE. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085911 ↗
• MalfunctionMar 22, 2018Low Readings; Low Readings

  STOCKED SENSORS WERE RETURNED BECAUSE LOW READING MATTER OCCURRED FREQUENTLY.

  Patient problems: No Patient Involvement

  MAUDE report 7361910 ↗

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.