MasimoSET® M-LNCS™ TC-I SpO2 Reusable Ear Sensor 2503Recalls & reported problems
Masimo Corporation · MasimoSET M-LNCS TC-I SpO2 Reusable Ear Sensor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843997003230), received between Jun 12, 2019 and Jun 12, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect Measurement” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
4 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.
Recalls naming this device
- Apr 21, 2023Class IIOpen, Classified
TC-I tip clip sensor may produce readings outside the accuracy specification.
Z-1986-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect Measurement1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8694190 ↗
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-1985-2023 · Apr 21, 2023 · Open, ClassifiedMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
- 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
- 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
Other Oximeter, ear devices
- MasimoSET LNCS® TC-I SpO2 Reusable Ear Sensor 1895Masimo Corporation · Oximeter, ear1 recall3 reports
- Portrait VSM MVC101Ge Medical Systems Information Technologies, Inc. · Oximeter, ear1 recall0 reports
- TruSignal SpO2 TS-SE-3GE Healthcare Finland Oy · Oximeter, ear1 recall0 reports
- V-Sign™ Sensor 2 VS-A/P/NSenTec AG · Oximeter, Ear1 recall0 reports
- MasimoSET® LNOP® TC-I SpO2 Reusable Ear Sensor 1794Masimo Corporation · Oximeter, ear1 recall0 reports
- Membrane Changer (single-use) / single unit MCSenTec AG · Oximeter, Ear1 recall0 reports
- TruSignal SpO2 TS-APGE Healthcare Finland Oy · Oximeter, ear1 recall0 reports
- TruSignal SpO2 TS-W-DGE Healthcare Finland Oy · Oximeter, ear1 recall0 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 · each recall links to the FDA recall notice
- 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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