Nellcor N600X-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521181229), received between Oct 4, 2017 and Jun 4, 2021 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K123581); 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 4, 2021Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE UNIT DID NOT ALARM. THIS WAS USED ON A PATIENT PARALYZED FROM NECK DOWN, WHO WAS ON A 24/7 VENTILATOR WITH FITTED PACEMAKER AND WAS FED USING A PEG TUBE. THE PATIENT DIED BECAUSE OF PNEUMONIA, WHICH WAS NOT ATTRIBUTED TO THE DEVICE USED.

  Patient problems: Bronchopneumonia

  MAUDE report 11940049 ↗
• DeathJan 12, 2021High Readings; High Readings

  DURING HOME MONITORING USE THE N600X-1 SPO2 PULSE RATE ALARM DID NOT GO OFF AT THE TIME OF PATIENT¿S DEATH. THE PATIENT WAS PARALYZED FROM THE NECK DOWN, VENTILATOR DEPENDENT WITH A PACEMAKER AND PEG TUBE FOR FEEDINGS. THE PACEMAKER WAS 10 YEARS OLD. THE PATIENT CAREGIVERS INFORMED THE POLICE THAT THE DEVICE DID NOT ALARM AT THE TIME OF DEATH, AND THAT ANOTHER MONITOR (MINDRAY) WAS BEING USED AT THE SAME TIME TO MONITOR THE HEARTBEAT WHICH WAS DECREASING. IT WAS REPORTED THAT THE N600X-1 WAS READING 60BPM, WHICH WAS WHAT THE PACEMAKER WAS SET TO. FOLLOWING THE EVENT, NHS TRUST PERFORMED 24-HOUR TESTING OF THE N600X-1 AND SIMULATED THE REDUCTION OF PULSE AND SATURATION AND THE DEVICE ALARMED AS NORMAL. PER THE REPORTER THE PATIENTS CAUSE OF DEATH WAS PNEUMONIA. THE DEVICE IT NOT RELATED TO THE CAUSE OF DEATH.

  Patient problems: Diminished Pulse Pressure

  MAUDE report 11157932 ↗
• MalfunctionMay 21, 2020Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS PLUGGED AND THE DEVICE SHORTED OUT. A BURNING SMELL WAS NOTED. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10079542 ↗
• MalfunctionOct 4, 2017Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED A REPORT STATING A N600X-1 PULSE OXIMETER FAILED TO ALARM. THERE WAS NO PATIENT HARM REPORTED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6914353 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123581. One submission often covers many models, so check the product and lot details in each record.

• Z-2268-2015 · Jun 29, 2015 · Terminated
  OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
• Z-2267-2015 · Jun 29, 2015 · Terminated
  OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.