Nellcor OxySoft OxySoftNRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521818972), received between Mar 22, 2023 and Aug 28, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (3 reports).

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.

• MalfunctionAug 28, 2025Incorrect Measurement; Defective Device; Incorrect Measurement; Defective Device

  IT WAS REPORTED THAT THE SENSOR HAD INCONSISTENT READINGS WITH MOTION AND A CABLE BREACH WAS IDENTIFIED. THE SENSOR WAS EXPOSED TO NATURAL LIGHTING, APPLIED TO THE FINGER, AND HELD IN PLACE WITHOUT ADDITIONAL SECURING METHODS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912226 ↗
• MalfunctionJul 9, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING USE ON A SMALL BABY, THE CUSTOMER DID A GAS AND THE PAO2 (ARTERIAL OXYGEN PRESSURE) WAS HIGH, 385 KILOPASCAL (KPA). A BROWN PROBE WAS USED AND THE SATURATION WERE GREAT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19703540 ↗
• MalfunctionJul 8, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING USE ON A SMALL BABY, THE CUSTOMER DID A GAS AND THE PAO2 (ARTERIAL OXYGEN PRESSURE) WAS HIGH, 385 KILOPASCAL (KPA). A BROWN PROBE WAS USED AND THE SATS WERE GREAT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19693261 ↗
• MalfunctionJan 31, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR WAS PLACED ON A PATIENT'S TINY MIDDLE FINGER. THE PATIENT WEIGHTED 12 KG BUT THE SENSOR WAS NOT INDICATED FOR BASED IN WEIGHT. IT WAS ALLEGED THAT THESE OPTICS WERE NOT ALIGNED CORRECTLY TO ALLOW FOR ANY ACCURACY. THE PATIENT HAD ABG (ARTERIAL BLOOD GAS) OF 80 AND THE OTHER SENSOR MEASURED 79 SPO2 WHICH APPEARED TO BE ALIGNED BASED ON SIZE DIFFERENCES AND STIFFNESS DIFFERENCES. HOWEVER, THE REPORTED SENSOR WAS AT 73 AND WAS NOT GETTING SPO2 READING CLOSED TO ABG READING. AN ADHESIVE SENSOR WRAP WAS USED TO HOLD SENSOR IN PLACE. THE SENSOR WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613415 ↗
• MalfunctionDec 15, 2023Erratic or Intermittent Display; Incorrect Measurement; Erratic or Intermittent Display; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR HAD INTERMITTENT AND INCORRECT READINGS. IT WAS ALSO MENTIONED THAT THERE WERE NOISY TRACE AND READINGS COMING AND GOING. THE SENSOR WAS PLACED ON THE PATIENT'S FINGER WITH A WRAP AND WAS CHECKED EVERY 4 HOURS. THE WAVEFORM BECAME GOOD AND THE READINGS WERE STABLE AND CORRECT WHEN THE PROBE WAS COVERED WITH A TOWEL. THE WAVEFORM AND READINGS STAYED THE SAME WHEN THE LIGHTS WAS TURNED OFF AND THE TOWEL WAS REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18338919 ↗
• InjuryAug 3, 2023Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE SENSOR WAS PLACED ON THE LEFT FOOT OF THE PATIENT DUE TO THE RADIAL ART LINE IN THE RIGHT WRIST. WHEN GAS WAS DRAWN AND DISCOVERED PARTIAL PRESSURE OF OXYGEN (PAO2), ANOTHER SENSOR WAS PLACED ON THE RIGHT ARM, AND IT WAS READING 100%. THE HEALTHCARE PROFESSIONAL BEGAN WEANING OXYGEN (O2) AND THEN PLACED THE SENSOR ON THE LEFT FOOT WHICH WAS READING 100%. THE PATIENT WAS ON HIGH FREQUENCY OSCILLATORY VENTILATION (HFOV) AND AUSCULTATION WAS DIFFICULT. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information; Upper Respiratory Tract Injury

  MAUDE report 17453617 ↗
• InjuryAug 3, 2023Incorrect Measurement; Low Readings; Incorrect Measurement; Low Readings

  ACCORDING TO THE REPORTER, THE SENSOR WAS PLACED ON THE LEFT FOOT OF THE PATIENT, BUT THE PATIENT DID HAVE A RIGHT RADIAL ARTERIAL LINE. PLETH WAS REPORTED BY BEDSIDE NURSE AS BEING NORMAL, BUT THE PATIENT WAS EXHIBITING LOW SATURATIONS INTO THE 80S. SPO2 READING WAS 89-87 WHILE SAO2 ON ABG 100% (DRAWN FROM RIGHT ARTERIAL LINE).OXYGEN WAS INCREASED AND AFTER SEVERAL HOURS OF INCREASING OXYGEN, THE NURSE NOTED THAT THE PATIENT'S COLOR AND PRESENTATION DID NOT MATCH THE CORRESPONDING SPO2 READINGS AND REQUESTED AN ABG. THE SUBSEQUENT PAO2 ON THE BLOOD GAS WAS >400. THE NURSE BEGAN WEANING OF OXYGEN AND REPLACED THE PROBE WITH A DIFFERENT ONE WHICH WAS READING 99-100%. LOCATION WAS IN SAME SPOT ON THE RIGHT FOREARM AREA OF THE BRACHIAL ARTERY. THE INCIDENT WAS REPORTED TO PHYSICIAN SERVICES AND THE PATIENT CONTINUED TO BE ABLE TO BE WEANED ON OXYGEN TO 30% OVER WITH NO OTHER INDICATION THAT SPO2 WAS NOT ACCURAT E. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450394 ↗
• MalfunctionMar 22, 2023Loss of or Failure to Bond; Delayed Program or Algorithm Execution; Loss of or Failure to Bond; Delayed Program or Algorithm Execution

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD A WEAK ADHESION AND REWINDING. THERE WAS A DELAY IN VALUE INDICATION. WHEN SENSOR WAS SECURED WITH SURGICAL TAPE ON PATIENT'S FOOT, THE SPO2 VALUE WAS DISPLAYED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593138 ↗