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U.S. Department of Health and Human Services

Class 2 Device Recall AVOXimeter 1000E

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 Class 2 Device Recall AVOXimeter 1000Esee related information
Date Initiated by FirmSeptember 27, 2024
Date PostedOctober 31, 2024
Recall Status1 Completed
Recall NumberZ-0279-2025
Recall Event ID 95497
510(K)NumberK922075 
Product Classification Oximeter - Product Code DQA
ProductAVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Code Information UDI-DI: 10711234530023. Serial Number: 6824
Recalling Firm/
Manufacturer		 Accriva Diagnostics, Inc.
6260 Sequence Dr
San Diego CA 92121-4358
For Additional Information Contact
858-263-2300
Manufacturer 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.
FDA Determined
Cause 2		Process change control
ActionOn 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 in Commerce1
DistributionUS: AZ
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = DQA
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