M-LNCS DCI SpO2 Adult Reusable Finger Clip Sensor 2501Recalls & reported problems
Masimo Corporation · M-LNCS DCI SpO2 Adult Reusable Finger Clip Sensor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00843997003193), received between Jul 11, 2017 and Apr 30, 2021 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Device Stops Intermittently” (7 reports).
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
- Device Stops Intermittently7
- Sensing Intermittently6
Patient problems
- No Consequences Or Impact To Patient11
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SENSOR SPORADICALLY SHOWS NO VALUES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11754281 ↗MalfunctionFeb 22, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SENSOR'S LED TURNED OFF WITH NO READINGS OR ERROR MESSAGES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8364489 ↗MalfunctionApr 6, 2018Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED: "INTERMITTENTLY LOSING SIGNAL.". NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7405545 ↗MalfunctionSep 21, 2017Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED INTERMITTENTLY WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES WITH NO ERROR MESSAGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6885218 ↗MalfunctionSep 15, 2017Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED INTERMITTENTLY WOULD DISPLAY VALUES AND THEN SUDDENLY NO VALUES WITH NO ERROR MESSAGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6867804 ↗MalfunctionSep 3, 2017Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED SENSOR INTERMITTENTLY WOULD DISPLAY VALUES THEN SUDDENLY NO VALUES, NO ERROR MESSAGE. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6840666 ↗MalfunctionAug 29, 2017Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED INTERMITTENTLY WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES WITH NO ERROR MESSAGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6826274 ↗MalfunctionAug 25, 2017Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED SENSOR INTERMITTENTLY WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES WITH NO ERROR MESSAGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6819673 ↗MalfunctionAug 25, 2017Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED SENSOR INTERMITTENTLY WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES WITH NO ERROR MESSAGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6819672 ↗MalfunctionAug 21, 2017Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED INTERMITTENT SIGNAL FAILURE. ADDITIONALLY, THE SENSOR WAS USED WITH A RC25-12 RAINBOW PATIENT CABLE ON A PHILIPS X2 MONITOR. THERE ARE NO ERROR MESSAGES. THE SENSOR INTERMITTENTLY STOPS WORKING. THE RED LIGHT TURNS OFF AND THE WAVEFORM ON THE MONITOR STOPS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6809263 ↗MalfunctionAug 21, 2017Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED: PROBLEM: ¿INTERMITTENTLY WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES WITH NO ERROR MESSAGE". NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6806632 ↗MalfunctionAug 21, 2017Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED: PROBLEM: ¿INTERMITTENTLY WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES WITH NO ERROR MESSAGE". NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6806629 ↗MalfunctionJul 11, 2017Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED: "INTERMITTENTLY WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES WITH NO ERROR MESSAGE" NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6704812 ↗
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-1986-2023 · Apr 21, 2023 · Open, ClassifiedMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
- 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-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-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 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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