Class II
Medical Device Recall: AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Accriva Diagnostics, Inc. · September 27, 2024
Reason for Recall
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.
Distribution
US: AZ
States Affected
AZ
Quantity Affected
1
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0279-2025
Status: completed
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