M-LNCS™ Adtx SpO2 Adult Pulse Oximeter Adhesive Sensor 2508Recalls & reported problems
Masimo Corporation · M-LNCS Adtx SpO2 Adult Pulse Oximeter Adhesive 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 10843997002506), received between May 12, 2017 and Aug 25, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Stops Intermittently” (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 18, 2026.
Most reported problems
Device problems
- Device Stops Intermittently2
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2017Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED THE LED WAS BLINKED, HOWEVER THE VALUES HAS BEEN DISPLAYED ON THE MONITOR INTERMITTENTLY. THE VALUE HAS BECOME TO BE DISPLAYED NORMALLY AS KNOWN PRODUCTS ONCE THE SENSOR REPLACED. THIS EVENT HAS BEEN OCCURRED WITHIN 1 MINUTE FROM THEY WRAPPED THE SENSOR AROUND THE PATIENT'S FINGER, AND NO PATIENT IMPACT. AT THAT TIME, THEY WERE ABOUT TO START THE MONITORING OF THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6819660 ↗MalfunctionMay 12, 2017Device Stops Intermittently; Device Stops Intermittently
IT WAS REPORTED THAT SENSOR INTERMITTENTLY LOOSES SIGNAL. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6565003 ↗
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 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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