INVOS RSC-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521145627), received between Feb 11, 2025 and Feb 11, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING USE, THE DEVICE HAD AN ABNORMAL MEASUREMENT VALUES. THE RSO2 VALUE DID NOT CHANGE FROM 80%. TWO CHANNELS WERE USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354306 ↗