Nellcor 10005941-SGRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10884521171534), received between Feb 5, 2018 and Feb 26, 2026 — classified as 4 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 23, 2025Open, Classified

   Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting

   Z-2151-2025 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Display or Visual Feedback Problem; Low Readings

  IT WAS REPORTED THAT, PRIOR TO USE, THE MONITOR HAD A BLANK DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464412 ↗
• MalfunctionDec 11, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE WAS SHOWING INCORRECT READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777344 ↗
• MalfunctionDec 10, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE WAS SHOWING INCORRECT READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767097 ↗
• MalfunctionDec 5, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE WAS SHOWING INCORRECT READING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728337 ↗
• InjurySep 18, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT DURING USE, IT WAS OBSERVED THAT THE INFANT'S LIPS WERE SLIGHTLY CYANOTIC, AND THE TRANSCUTANEOUS OXYGEN SATURATION FLUCTUATED AND DROPPED TO AROUND 80%. HOWEVER, THE OXYGEN SATURATION MONITOR DID NOT ALARM OR POSSIBLY ALARMED, BUT THE ALARM SOUND WAS NOT NOTICEABLE AND WAS CONFUSED WITH SOUNDS FROM OTHER DEVICE IN THE WARD, CAUSING MEDICAL STAFF FAILURE TO NOTICE IN TIME. THE INFANT'S CONDITION IMPROVED AFTER STIMULATION.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23083685 ↗
• MalfunctionAug 11, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE MONITOR DISPLAYED IMPROPER READINGS DURING PRE-OPERATIVE PREPARATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770874 ↗
• MalfunctionAug 1, 2025Incorrect Measurement; Failure to Analyze Signal; Incorrect Measurement; Failure to Analyze Signal

  IT WAS REPORTED THAT THE DEVICE READING WAS INACCURATE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690310 ↗
• MalfunctionJan 24, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING USE, SMOKE EMITTED FROM THE POWER CONNECTION AND A BURNING SMELL WAS NOTICED. THE EQUIPMENT WAS REPLACED WITH ONE THAT HAD A DIFFERENT BURNING SMELL. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21229004 ↗
• MalfunctionJan 17, 2025Incorrect Measurement; Failure to Analyze Signal; Incorrect Measurement; Failure to Analyze Signal

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE HAD IMPROPER READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178292 ↗
• MalfunctionDec 6, 2024Image Display Error/Artifact; Incorrect Measurement; Use of Device Problem; Image Display Error/Artifact; Incorrect Measurement; Use of Device Problem

  IT WAS REPORTED THAT THE MACHINE WAS NOT MEASURING HEART RATE AND PULSE RATE CORRECTLY WHILE CONNECTING TO PROBES AND INTERMITTENTLY SHOWING AN ERROR 804. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864352 ↗
• MalfunctionDec 4, 2024Incorrect Measurement; Low Readings; Incorrect Measurement; Low Readings

  ACCORDING TO THE REPORTER, THE BABY'S BLOOD OXYGEN SATURATION NEEDED TO BE TESTED IMMEDIATELY AFTER BIRTH TO CHECK FOR INSUFFICIENT OXYGEN SUPPLY. IF THE SATURATION WAS TOO LOW, SYMPTOMS SUCH AS DIFFICULTY BREATHING AND A PURPLE COMPLEXION COULD OCCUR, AFFECTING THE NEWBORN'S HEALTH. WHEN THE PULSE OXIMETER WAS USED TO MONITOR THE BABY, IT CONSISTENTLY SHOWED READINGS BETWEEN 70% AND 80%. THE PEDIATRICIAN SUSPECTED POOR CONTACT OR THAT THE NEWBORN WAS TOO SMALL, SO THE DEVICE WAS KEPT ON, BUT IT STILL ONLY SHOWED AROUND 80%, EVEN THOUGH THE BABY WAS CRYING LOUDLY. THE DOCTOR THEN USED AN ECG (ELECTROCARDIOGRAM) MONITOR, WHICH SHOWED READINGS ABOVE 90%. BASED ON THE DOCTOR'S EXPERIENCE, ON-SITE OBSERVATION, AND AUSCULTATION, THE BABY WAS JUDGED EVALUATED TO BE HEALTHY. AFTER TWO HOURS OF OBSERVATION WITH NO SIGNS OF DISCOMFORT, THE BABY WAS TRANSFERRED TO THE WARD WITH THE MOTHER FOR FURTHER TESTING. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20841760 ↗
• MalfunctionNov 7, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT READ WRONG OUTPUT. USED NEONATE SENSOR AND TRIED TO USE AND COMPARED THAT SENSOR W ITH OTHER PULSE OXIMETER UNIT THAT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631528 ↗
• MalfunctionNov 6, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD A LOW READING. NORMALLY, IT WAS 98 BUT IT SHOWED 95. THERE WERE AUDIBLE AND VISUAL ALARMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622205 ↗
• MalfunctionOct 29, 2024Incorrect Measurement; Use of Device Problem; Incorrect Measurement; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE BUTTON WAS DEFECTIVE AND HAD AN INACCURATE VALUES. THE USER TESTED THE PRODUCT ON THEIR OWN FINGER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559462 ↗
• MalfunctionAug 22, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING TESTING, THE DEVICE HAD AN ALLEGED INACCURATE SATURATION VALUE WITHOUT OTHER DEVICES COMPARED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20025490 ↗
• MalfunctionJul 17, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE BLOOD OXYGEN MEASURED BY THE UNIT WERE ALL TOO LOW. ANOTHER MACHINE WAS USED TO MEASURE AND THE DATA WAS NORMAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759667 ↗
• MalfunctionJan 31, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE MEASURED VALUE OF THE UNIT WAS NOT ACCURATE. THERE WERE VISIBLE READINGS OF 78 AND 97. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613628 ↗
• InjuryJan 26, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, AFTER 4 DAYS OF OXYGEN INHALATION, THE PATIENT'S SPO2 LEVEL WAS STILL BETWEEN 93% AND 95%. THE UNIT WAS CHANGED TO TELEMETRY MONITORING AND SHOWED THAT THE OXYGEN SATURATION WAS ABOVE 96%. MONITORING VALUES FROM THE REPORTED UNIT WERE INACCURATE AND WAS 2-3 VALUES LOWER FROM OTHER MACHINES. THE PATIENT REQUIRED EXTEND OYGEN INHALATION TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18590673 ↗
• MalfunctionSep 11, 2023Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE PRODUCT GAVE LOW READINGS. THE PATIENT'S TRANSCUTANEOUS OXYGEN SATURATION SHOWED AN OXYGEN SATURATION OF 89% AND A HEART RATE OF 99 BEATS/MIN DURING THE DETECTION PROCESS. THE ASSESSMENT DID NOT MATCH THE ACTUAL SITUATION. AFTER REPEATED COMPARISONS, IT WAS FOUND THAT THE ERROR OF THE VALUE WAS 8%, AND THE ERROR OF THE HEART RATE WAS 30 BEATS/MIN. THE 8% VALUE WAS LOWER THAN EXPECTED AND THE 30 BEATS/MINUTE WAS ALSO LOWER THAN EXPECTED. THE EXPECTED READINGS WERE AT 97%. IT WAS FOUND THAT THERE WAS AN ERROR IN THE PRODUCT. IT WAS IMMEDIATELY REPLACED WITH ANOTHER MONITOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17723428 ↗
• MalfunctionAug 8, 2023Image Display Error/Artifact; Incorrect Measurement; Image Display Error/Artifact; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE DEVICE WAS GIVING AN ERROR MESSAGE THAT IT WAS UNABLE TO LOAD INTO WORKING MODE DUE TO THE DISCONNECTED CABLE INSIDE THE OXIMETER AND NOTHING TO DO WITH THE ALARM. THE PROBLEM WAS FIXED AFTER IT WAS RECONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481936 ↗
• MalfunctionMar 17, 2023Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, THE DEVICE SHORT-CIRCUITED AND BURNED. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564518 ↗
• InjuryOct 12, 2022Device Alarm System; No Display/Image; Defective Component; Device Alarm System; No Display/Image; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD TURNED BLACK WHEN INSPECTING THE WARD AND THERE WAS NO ALARM. FAILED TO OBSERVE THE CONDITION IN TIME DUE TO BEING IN STANDBY STATE FOR A LONG TIME AND THERE WERE PROBLEMS WITH INTERNAL PARTS OR CIRCUITS. IT WAS REPLACED IT WITH ANOTHER PULSE OXIMETER, AND CONTINUED MONITORING VITAL SIGNS, AND CLEARLY IDENTIFIED THE FAULT. THERE WAS A PATIENT SERIOUS INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15592653 ↗
• MalfunctionSep 6, 2022Device Alarm System; Image Display Error/Artifact; Noise, Audible; Device Alarm System; Image Display Error/Artifact; Noise, Audible

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD AN ERROR CODE 910. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE UNIT HAD A DEFECTIVE SPEAKER AND THERE WAS NO ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15364665 ↗
• MalfunctionFeb 25, 2022Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SENSOR CABLE STOPPED WORKING AND THE CONNECTING PORT GOT BURNED. BURN MARK WAS IN OXI - AN SENSOR WHICH WAS CLOSER TO THE PATIENT CONNECTOR. ALL THE SENSORS STOP WORKING DURING USAGE ON PATIENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13601141 ↗
• MalfunctionFeb 25, 2022Defective Device; Defective Device

  ACCORDING TO THE REPORTER, THE UNIT CABLE STOP WORKING. SENSOR GOT BURNED TO THE CONNECTING PORT TO THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13601058 ↗