FDA Medical Device Recalls (openFDA)
Accriva Diagnostics, Inc.: AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
- Recall number
- Z-0279-2025
- Recalling firm
- Accriva Diagnostics, Inc.
- Product
- AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
- Status
- Completed
- Initiated
- 2024-09-27
- Posted
- 2024-10-31
- Terminated
- not on file
- 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.
- Root cause
- Process change control
- Action
- On 9/27/24, a recall notice was sent to a customer informing them to do the following: 1) This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where the potentially affected device has been transferred.. 2. Call Technical Support 1-800-678-0710 to initiate a Service Call and Returned Material Authorization 3. Complete and return the customer response form via email to For technical questions contact Technical Support at the number above or email techsupport.na@werfen.com.
- Quantity
- 1
- Distribution
- US: AZ
- Lot, serial or model codes
- UDI-DI: 10711234530023. Serial Number: 6824
- 510(k) numbers
- ["K922075"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 2250033
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28