AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Reported: November 6, 2024 Initiated: September 27, 2024 #Z-0279-2025
Product Description
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
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.
Details
- Recalling Firm
- Accriva Diagnostics, Inc.
- Units Affected
- 1
- Distribution
- US: AZ
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.. Recalled by Accriva Diagnostics, Inc.. Units affected: 1.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2024. Severity: Moderate. Recall number: Z-0279-2025.
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