BCI 3025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517042528), received between Oct 28, 2021 and Jun 4, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE READING ON THE DEVICE WAS LOW BUT WAS NORMAL IN THE ER. ONE LIGHT WAS NOT LIT ON THE SENSOR. EVENT OCCURRED IN A DOCTOR'S OFFICE WHILE IN USE WITH PATIENT AND WAS OPERATED BY A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459841 ↗
• MalfunctionOct 28, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE SENSOR ON A SMITHS MEDICAL OXIMETER DOES NOT TURN ON, BUT THE OTHER SENSORS STILL WORK ON THE SAME MONITOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12716112 ↗