Nellcor MAXAIRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20884522040072), received between Dec 2, 2022 and Sep 2, 2025 — classified as 2 injuries, 6 malfunctions.

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

• MalfunctionSep 2, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE ARREST PAGE WENT OFF EVEN THOUGH THE SENSOR WAS STILL ATTACHED TO THE PATIENT'S FOREHEAD. IT WAS FOUND THAT THE SENSOR WAS APPLIED ON FOREHEAD INSTEAD OF THE FINGER WHICH LED TO UNRELIABLE READINGS. NO PATIENT OUTCOME WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22932134 ↗
• MalfunctionAug 28, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE ARREST PAGE WENT OFF EVEN THOUGH THE SENSOR WAS STILL ATTACHED TO THE PATIENT'S FOREHEAD. IT WAS FOUND THAT THE SENSOR WAS APPLIED ON FOREHEAD INSTEAD OF THE FINGER WHICH LED TO UNRELIABLE READINGS. NO PATIENT OUTCOME WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22913317 ↗
• MalfunctionAug 11, 2025Device Alarm System; Incorrect Measurement; Device Alarm System; Incorrect Measurement

  IT WAS REPORTED THAT THE UNIT'S ARREST PAGE ALARM WENT OFF AND THE PATIENT HAD AN ADHESIVE FINGER PLETH ATTACHED TO HER FOREHEAD. IT WAS ADVISED THAT FOREHEAD PLETHS WERE NOT LICENSED FOR USE ON THE FOREHEAD, AS IT WAS RESULTING IN UNRELIABLE READINGS. THERE APPEARED TO BE NO MENTION OF FOREHEAD USE ON THE PACKAGING OR IN THE INSTRUCTIONS INCLUDED IN THE BOX. THE DIAGRAMS PROVIDED ONLY DEMONSTRATE PROPER USAGE ON THE FINGER. IT WAS UNKNOWN IF THERE WAS ANY PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22770781 ↗
• MalfunctionJul 23, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR GAVE LOW SPO2 READINGS. THE SELF-CONTAINED TAPE WAS USED TO HOLD IT IN PLACE. THE PATIENT¿S SKIN CONDITION AND CIRCULATORY STATUS WAS GOOD. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804585 ↗
• InjuryMay 2, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DISPLAYED VALUE DID NOT MATCH THE PATIENT'S CONDITION. THE PATIENT SHOWED SYMPTOMS OF HYPOXIA. IN ORDER TO MONITOR THE PATIENT'S BLOOD OXYGEN SATURATION, THE MONITORING VALUE WAS 96%, WHICH WAS INCONSISTENT WITH THE CONDITION. MONITORING USING OTHER MACHINES WAS 85%. REPLACED THE BLOOD OXYGEN SENSOR WITH A NEW ONE AND THE DISPLAYED VALUE WAS 85%.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19229519 ↗
• MalfunctionJan 31, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DISPOSABLE SENSOR GAVE A SATURATION VALUE TWO POINTS BELOW DURASENSOR IN A COVID PATIENT IN THE WARD TO DISCHARGE. IT WAS INDICATED THAT THE DURASENSOR GAVE CORRECT VALUES BUT THE PATIENT'S SENSOR DID NOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619617 ↗
• MalfunctionAug 4, 2023High Readings; Delayed Program or Algorithm Execution; High Readings; Delayed Program or Algorithm Execution

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SENSOR WAS NO LONGER STUCK TO THE FINGER AND IT WAS HUNG IN THE AIR FOR ABOUT A MINUTE, IT WAS PRESENTED WITH A HIGH SPO2 READING (FURTHER SATURATION OF 100). THE PATIENT¿S SKIN CONDITION WAS NORMAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17463843 ↗
• InjuryDec 2, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT SUSTAINED FULL THICKNESS BURNS TO ARM. THE SPO2 PROBE WAS NOT REMOVED PRIOR TO PATIENT HAVING AN MRI. THE PATIENT WAS HAVING AN ONGOING BURN TREATMENT AND DRESSING WAS APPLIED.

  Patient problems: Burn(s)

  MAUDE report 15906056 ↗

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.