Nellcor GR101704Recalls & reported problems
Covidien LP · Bedside Respiratory Patient Monitoring System · Class 2
All models of Nellcor (64)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521138681), received between Apr 20, 2018 and Jan 30, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Image Display Error/Artifact” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Image Display Error/Artifact2
- Device Alarm System1
- Failure of Device to Self-Test1
- Failure to Power Up1
- High Readings1
- Incorrect Measurement1
- Loss of Data1
- Noise, Audible1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2026Incorrect Measurement; Loss of Data
IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, THE DEVICE EXHIBITED INTERMITTENT READING DROP AND THE INABILITY TO ERASE TREND DATA. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225705 ↗MalfunctionNov 5, 2025Device Alarm System; Image Display Error/Artifact; Failure of Device to Self-Test; Device Alarm System; Image Display Error/Artifact; Failure of Device to Self-Test
IT WAS REPORTED THAT A NURSE CALL ERROR OCCURRED AND THE DEVICE FAILED THE INITIAL POWER ON SELF TEST (POST). ADDITIONALLY, THE ALARM DID NOT FUNCTION BUT ALARMED WHEN ERROR CODE 11 COMING UP THAT STATED, "UNIT FAIL TO FINISH POST". THE MONITOR WAS POWER CYCLED AS A TROUBLESHOOTING STEP. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23482854 ↗MalfunctionJun 16, 2021Failure to Power Up; Temperature Problem; Failure to Power Up; Temperature Problem
ACCORDING TO THE REPORTER, THE UNIT WOULD TURN ON, THE POWER /SUPPLY/ADAPTOR OVERHEATED AND STARTED SMOKING. IT WAS INDICATED THAT THE POWER SUPPLY WAS SWAPPED, CHECKED FUSES AND POWER CYCLED THE UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12008493 ↗MalfunctionFeb 24, 2020High Readings; High Readings
ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD A VERY HIGH READING. IT WAS STATED THAT THE PULSE READING WAS 187. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9747135 ↗MalfunctionApr 20, 2018Image Display Error/Artifact; Noise, Audible; Image Display Error/Artifact; Noise, Audible
ACCORDING TO THE REPORTER, THE DEVICE HAD A TASK 1 SPEAKER FAILURE UPON POWER ON AND NO AUDIBLE ALARM. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7449000 ↗
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- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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