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U.S. Department of Health and Human Services

Class 2 Device Recall AVOXimeter 1000, AVOXimeter 4000

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 Class 2 Recall
AVOXimeter 1000, AVOXimeter 4000
see related information
Date Posted May 19, 2011
Recall Status1 Terminated on October 25, 2012
Recall Number Z-2218-2011
Recall Event ID 58549
Premarket Notification
510(K) Numbers
K922075  K951485 
Product Classification Oximeter - Product Code DQA
Product AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use int he cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated.
Code Information AVOXimeter 1000: K922075 AVOX1000, AVOX1000E-110, AVOX1000INT AVOXimeter 4000: K951485 AVOX4000, AVOX4000D
Recalling Firm/
Manufacturer
International Technidyne Corp.
68 Olsen Ave
Edison, New Jersey 08820-2419
For Additional Information Contact Mr. Larry Picciano
732-548-5700 Ext. 4451
Manufacturer Reason
for Recall
An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.
FDA Determined
Cause 2
DESIGN: Device Design
Action International Technidyne Corp. sent a letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory to determine if they have any of the affected product. If they have any of the affected product, customers were instructed to stop using it and remove it from their inventory. Customers were also instructed to complete the attached Customer Account Tracking Form and return it by fax to (732-635-0144) or e-mail (techsupport@itcmed.com) or mail to: ITC Technical Support 20 Corporate Place South Piscataway, New Jersey 08854 For any questions call the Distributor or ITC Nexus Dx Technical Support at 800-631-5945 (US) or 732-548-5700 (International), ext 4707.
Quantity in Commerce 17
Distribution Worldwide Distribution - USA including TX, KS, OH, OR, FL, GA, NY, MA, and DC and the countries of Taiwan and Thailand
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQA and Original Applicant = A-VOX SYSTEMS, INC.
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