Nellcor MAXI-NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884522041284), received between Apr 25, 2025 and Jul 9, 2025 — classified as 4 malfunctions.

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

• MalfunctionJul 9, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT THE NEWBORN PATIENT'S O2 SATURATION READING ON THE RIGHT WRIST AND RIGHT FOOT WAS REPORTED TO BE 88-93%. FOLLOWING THE SECOND PULSE OXYGEN TEST, THE O2 SATURATION ON THE RIGHT WRIST AND RIGHT FOOT WAS 88%-90%. AN OXYGEN SATURATION READING OF 98% WAS OBTAINED ON THE RIGHT FOOT WHEN ANOTHER PULSE OXIMETER WAS USED. THE PULSE OXIMETER THAT WAS ATTACHED TO THE RIGHT WRIST WAS REMOVED, AND THE PULSE OXIMETER FROM THE RIGHT FOOT WAS MOVED TO THE RIGHT WRIST AND DISPLAYED O2 SATURATION OF 98%. THE INFANT WAS IN THE RADIANT WARMER UNDER PHOTOTHERAPY BUT THE PHOTOTHERAPY LIGHTS WERE TURNED OFF. THE PATIENT HAD A FAIR SKIN STONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461232 ↗
• MalfunctionJul 9, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT THE NEWBORN PATIENT'S O2 SATURATION READING ON THE RIGHT WRIST AND RIGHT FOOT WAS REPORTED TO BE 88-93%. FOLLOWING THE SECOND PULSE OXYGEN TEST, THE O2 SATURATION ON THE RIGHT WRIST AND RIGHT FOOT WAS 88%-90%. AN OXYGEN SATURATION READING OF 98% WAS OBTAINED ON THE RIGHT FOOT WHEN ANOTHER PULSE OXIMETER WAS USED. THE PULSE OXIMETER THAT WAS ATTACHED TO THE RIGHT WRIST WAS REMOVED, AND THE PULSE OXIMETER FROM THE RIGHT FOOT WAS MOVED TO THE RIGHT WRIST AND DISPLAYED O2 SATURATION OF 98%. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461188 ↗
• MalfunctionMay 7, 2025Incorrect Measurement; Defective Device; Incorrect Measurement; Defective Device

  IT WAS REPORTED THAT AN SPO2 SENSOR WAS NOT GETTING ACCURATE READINGS. THE USER CHECKED IF THE PRODUCT WAS ON AND FOUND EXPOSED WIRES. THE END WAS PULLED APART AND TAPED OFF, REVEALING THE WIRES. NO PATIENT COMPLICATIONS OR HARMS WERE REPORTED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979070 ↗
• MalfunctionApr 25, 2025Low Readings; Defective Device; Low Readings; Defective Device

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE USE, A NURSE NOTED LOW OXYGEN SATURATION LEVELS AND INVESTIGATED WHETHER TO REPLACE THE SENSOR OR SIMPLY REATTACH IT, AS IT HAD BEEN REPLACED TWO TO THREE HOURS EARLIER. UPON REMOVING THE SOCK THAT WAS KEEPING IT IN PLACE, IT WAS FOUND THAT THE TAPE WAS OFF AND WIRES WERE EXPOSED ON THE SENSOR. NUMERICAL VALUES SHOWED 60S-70S%, WHEREAS THEY HAD BEEN GREATER THAN 92% EARLIER. THE MONITOR WAS SET TO GENERAL PEDIATRIC SETTINGS. A NEW PROBE WAS PLACED, WHICH AGAIN SHOWED VALUES GREATER THAN 92%. THERE WAS NO VISUAL ALARM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910541 ↗

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.