Avoximeter Whole Blood CO-Oximeter AVOX4000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10711234530054), received between Jan 8, 2018 and Jan 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K951485); 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 18, 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.

• MalfunctionJan 8, 2018High Test Results; High Test Results

  HEALTHCARE PROFESSIONAL REPORTED AN UNEXPECTEDLY HIGH %COHB RESULT WITH AN AVOXIMETER 4000 CO-OXIMETER IN A CONTINUOUSLY VENTILATED NURSING HOME PATIENT. BLOOD GASES AND CO-OXIMETRY TESTS WERE BEING CONDUCTED EVERY 12 HOURS. TEST RESULTS WERE AS EXPECTED EXCEPT FOR ONE UNEXPECTEDLY HIGH %COHB RESULT (5.2%) THAT WAS CLINICALLY SIGNIFICANT AND ABOVE THE PATIENT'S 48-HOUR BASELINE %COHB OF 2.1%. THE PATIENT RECEIVED AN UNSPECIFIED TREATMENT AND SUBSEQUENT BLOOD GASES AND CO-OXIMETER RESULTS RETURNED TO BASELINE. AN INTERNAL INVESTIGATION DID NOT FIND ANY EVIDENCE THAT THE PATIENT WAS EXPOSED TO CARBON MONOXIDE. NO MEDICAL COMPLICATIONS OR OTHER EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7173967 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951485. One submission often covers many models, so check the product and lot details in each record.

• Z-2218-2011 · Mar 23, 2011 · Terminated
  AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content.
• Z-1239-2008 · Feb 13, 2008 · Terminated
  International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220