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U.S. Department of Health and Human Services

Class 2 Device Recall AVOXimeter 4000

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 Class 2 Device Recall AVOXimeter 4000 see related information
Date Posted August 06, 2008
Recall Status1 Terminated on July 24, 2009
Recall Number Z-1239-2008
Recall Event ID 46773
510(K)Number K951485 
Product Classification oximeter - Product Code JKS
Product International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220
Code Information 41018
41068
41096
41124
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Q-1034
Catalog/Code Numbers: AVOX4000-110 and AVOX4000-220.
Recalling Firm/
Manufacturer
International Technidyne Corp.
6-8 Olsen Ave
Edison NJ 08820-2419
732-548-5700
For Additional Information Contact John Salerno
732-548-5700
Manufacturer Reason
for Recall
Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.
FDA Determined
Cause 2
Process design
Action ITC sent Urgent - Medical Device Field Recall - ITC No. 08-001 letters dated 2/08/2008 to hospitals and/or medical facilities identified as having affected instruments. The letter instructed users not to use the instrument if the diagnostic mode is enabled. ITC will reset affected devices and return them to the customers.
Quantity in Commerce 61 US, 2 International
Distribution Worldwide Distribution: USA, United Arab Emirates, Malaysia, Saudi Arabia, India, Germany, United Kingdom, Greece, Romania, Singapore, ROC, Pakistan, Netherlands, Korea, France, Belgium, Switzerland, Canada, Thailand, Slovenia, Turkey and Australia.
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 = JKS and Original Applicant = A-VOX SYSTEMS, INC.
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