FORESIGHT ELITE FSEO2004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103208597), received between Sep 14, 2021 and Sep 14, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

1 other recall cover devices cleared under the same FDA submission (K143675); 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 16, 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.

• MalfunctionSep 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE FSEO2004 STARTED GIVING NUMBERS THAT ARE OUTSIDE THE SIMULATOR CALIBRATED RANGE. WHEN THE SIMULATOR IS CONNECTED THE READINGS SHOULD BE WITHIN 10 PERCENT OF 65. THE READINGS ARE EITHER HIGH OR LOW AND THUS NOT CALIBRATED. THIS WAS BEFORE USE. THERE IS NO PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468929 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143675. One submission often covers many models, so check the product and lot details in each record.

• Z-0834-2022 · Mar 1, 2022 · Open, Classified
  FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.