MasimoSET® LNCS® TF-I SpO2 Reusable Forehead Sensor 1896Recalls & reported problems
Masimo Corporation · MasimoSET LNCS TF-I SpO2 Reusable Forehead Sensor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843997000055), received between Feb 28, 2019 and Aug 27, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Readings” (1 report).
5 other recalls cover devices cleared under the same FDA submission (K051212); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- High Readings1
- Incorrect Measurement1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2019High Readings; High Readings
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED HIGH READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8936635 ↗MalfunctionFeb 28, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE SENSOR IS GIVING INACCURATE SPO2 READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8379914 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K051212. One submission often covers many models, so check the product and lot details in each record.
- Z-1986-2023 · Apr 21, 2023 · Open, ClassifiedMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
- Z-1985-2023 · Apr 21, 2023 · Open, ClassifiedMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
- Z-2640-2017 · Apr 4, 2016 · TerminatedSpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human pa
- Z-2642-2017 · Apr 4, 2016 · TerminatedMasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures,
- Z-2641-2017 · Apr 4, 2016 · TerminatedMasimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient und
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- 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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