Nellcor MAXALJRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884522042505), received between Nov 6, 2018 and Sep 15, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Readings” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE WAVEFORMS WERE NOT DISPLAYED AND THE SPO2 VALUE WAS INACCURATELY SHOWN AS 20%. THE SENSOR WAS REPLACED AND THE READINGS WERE DISPLAYED CORRECTLY. THE ISSUE WAS OBSERVED DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057677 ↗
• MalfunctionFeb 3, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE'S SPO2 VALUE BECAME LOW WHEN THE SENSOR WAS USED. WHEN IT WAS REPLACED WITH ANOTHER SENSOR, IT WAS LOWER THAN USUAL, BUT IT WAS NOT AS LOW AS THE REPORTED SENSOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637190 ↗
• MalfunctionJul 3, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR READING WAS LOW (97%). AFTER IT WAS REPLACED, IT BECAME 100%. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8757709 ↗
• MalfunctionNov 7, 2018Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE'S SPO2 LEVEL WAS LOWER THAN THE READINGS PROVIDED WITH SENSOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8047517 ↗
• MalfunctionNov 6, 2018Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT'S READING FELL AS LOW AS 5% AND PROVIDED LOW READINGS. A CUSTOMER INDICATED THAT THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8041136 ↗

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.