Nellcor N65Recalls & reported problems
Covidien LP · OXIMAX N-65 Handheld Pulse Oximeter · Class 2
Data updated Oct 13, 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 10884521096752), received between Apr 18, 2018 and Aug 9, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Alarm System2
- Poor Quality Image2
- Failure to Analyze Signal1
- Low Readings1
- Manufacturing, Packaging or Shipping Problem1
- Noise, Audible1
Patient problems
- No Patient Involvement3
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2024Low Readings; Low Readings
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD A LOW READING OF ABOUT 10. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19948592 ↗MalfunctionSep 23, 2020Device Alarm System; Failure to Analyze Signal; Device Alarm System; Failure to Analyze Signal
ACCORDING TO THE REPORTER, THE DEVICE ALARM CAME OFF AND CANNOT MEASURE EVEN IF THE BATTERY WAS REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.
Patient problems: Insufficient Information; No Information
MAUDE report 10572521 ↗MalfunctionJan 3, 2020Device Alarm System; Manufacturing, Packaging or Shipping Problem; Noise, Audible; Device Alarm System; Manufacturing, Packaging or Shipping Problem; Noise, Audible
ACCORDING TO THE REPORTER, THE DEVICE DID NOT GENERATED SOUNDS AND IT WAS FAILURE OUT OF BOX. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9546599 ↗MalfunctionJul 29, 2019Poor Quality Image; Poor Quality Image
ACCORDING TO THE REPORTER, THE UNIT HAD MISSING SEGMENT OF THE READING ON THE LCD SCREEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8838425 ↗MalfunctionApr 18, 2018Poor Quality Image; Poor Quality Image
ACCORDING TO THE REPORTER, THE UNIT HAD PARTIALLY MISSING SEGMENTS. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7440396 ↗
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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