Nellcor MAXPJRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884522042304), received between Oct 5, 2022 and Jun 9, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delayed Program or Algorithm Execution” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING USE OF THE SENSOR, THE PATIENT HAD BURN INJURY. THE SENSOR WAS NEEDED TO BE REPOSITIONED EVERY 3-4 HOURS. THE BURN INJURY CAUSED BY THE SENSOR IS LOCATED AROUND THE EDGES OF THE SENSOR REGION.

  Patient problems: Burn(s)

  MAUDE report 25448982 ↗
• MalfunctionJun 2, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING USE OF THE SENSOR, THE PATIENT HAD BURN INJURY IN THE LEFT THUMB. THE SENSOR WAS NEEDED TO BE REPOSITIONED EVERY 3-4 HOURS. THE BURN INJURY CAUSED BY THE SENSOR IS LOCATED AROUND THE EDGES OF THE SENSOR REGION. AFTERWARD, A DIFFERENT SENSOR MODEL WAS ATTACHED TO THE INDEX TOE OF RIGHT FOOT, BUT A BURN OCCURRED WITH THE SENSOR AS WELL.

  Patient problems: Burn(s)

  MAUDE report 25360896 ↗
• MalfunctionOct 21, 2022Low Readings; Delayed Program or Algorithm Execution; Low Readings; Delayed Program or Algorithm Execution

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SPO2 VALUE WAS LOW. THE AVERAGE HAS BEEN 98% BUT THE VALUE WAS LOW AT 92%. IT WOULD TAKE TIME UNTIL THE VALUES WERE DISPLAYED AND TO APPEAR AGAIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651296 ↗
• MalfunctionOct 5, 2022Low Readings; Delayed Program or Algorithm Execution; Low Readings; Delayed Program or Algorithm Execution

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SPO2 VALUE WAS LOW. THE AVERAGE HAS BEEN 98% BUT THE VALUE WAS LOW AT 92%. IT WOULD TAKE TIME UNTIL THE VALUES WERE DISPLAYED AND TO APPEAR AGAIN. THERE WAS MINOR INJURIES AND PATIENT FELT DISCOMFORT IN TERMS OF SENSATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546447 ↗

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.