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Recall Observatory FDA recall evidence

Device product

AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.

Z-0279-2025

September 27, 2024

Class II

Product summary

Firm
Accriva Diagnostics, Inc.
Event
Event 95497
Status
Completed
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0279-2025

Official wording

Reason: 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.

Code information: UDI-DI: 10711234530023. Serial Number: 6824

Distribution pattern: US: AZ

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.