LNCS-II rainbowRecalls & reported problems across all models
Masimo Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one LNCS-II rainbow model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of LNCS-II rainbow by Masimo Corporation in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Apr 24, 2025 and Apr 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Sense” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
LNCS-II rainbow recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 21, 2025Open, Classified
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
Z-1184-2025 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
Most reported LNCS-II rainbow problems
Device problems
- Failure to Sense1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
LNCS-II rainbow models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LNCS-II rainbow 4067Oximeter1 recall1 report
- LNCS-II rainbow 4068Oximeter1 recall0 reports
Recent LNCS-II rainbow adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2025Failure to Sense; Failure to Sense
THE CUSTOMER REPORTED THE SENSOR HAS "STOPPED TAKING MEASUREMENTS." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21904855 ↗
Other Masimo Corporation products
- RAD-G4 models · 194 reports · 4 recalls
- Rad-973 models · 330 reports
- Rad-8 Horizontal Signal Extraction Pulse Oximeter2 models · 123 reports
- Radius VSM7 models · 13 reports · 2 recalls
- RD SET12 models · 49 reports · 1 recall
- Rad-5 Handheld signal extraction pulse oximeter2 models · 76 reports
- Rad-5v Handheld signal extraction pulse oximeter2 models · 46 reports
- Radius-73 models · 35 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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