Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0279-2025 — AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.

U.S. FDA — Device Enforcement · United States · 2024-09-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0279-2025
Date of alert
2024-09-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Accriva Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10711234530023
Reported risk: Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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