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U.S. Department of Health and Human Services

Class 2 Device Recall AVOXimeter 1000

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 Class 2 Recall
AVOXimeter 1000
see related information
Date Posted August 06, 2008
Recall Status1 Terminated on July 24, 2009
Recall Number Z-1237-2008
Recall Event ID 46773
Premarket Notification
510(K) Number
K922075 
Product Classification Oximeter - Product Code DQA
Product International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220
Code Information Serial Numbers: 1073, 1085, 1197, 1245, 1321, 1383, 1162. Catalog Numbers/Code: AVON1000-110 and AVOX-1000-220. Note:w The AVOXimeter 1000 was discontinued in 1996 by the company which which ITC acquired the product line from (AVOX Systems in Texas. Today, only service is offered on this mode.
Recalling Firm/
Manufacturer
International Technidyne Corp.
6-8 Olsen Ave
Edison, New Jersey 08820-2419
Consumer Instructions Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.
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
DESIGN: 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 7 units
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 = DQA and Original Applicant = A-VOX SYSTEMS, INC.
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