FDA Device recall Z-0279-2025
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter
- FDA Device
- Class II
- completed
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter by Accriva Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0279-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-09-27 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Accriva Diagnostics |
| Distribution | AZ |
Product
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
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.
Identifiers
| code_info | UDI-DI: 10711234530023. Serial Number: 6824 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0279-2025%22
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