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U.S. Department of Health and Human Services

Class 2 Device Recall AVOXimeter 4000

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 Class 2 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
Premarket Notification
510(K) Number
K922075 
Product Classification Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide - 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 41146 41175 41280 41323 41325 41384 41423 41430 41453 41480 41484 41489 41505 41506 41532 41533 41555 41560 41566 41570 41571 41572 41573 41574 41575 41576 41577 41578 41578 41579 41580 41581 41582 41582 41583 41584 41585 41586 41588 41589 41592 41593 41594 41595 41601 41605 41607 41608 41609 41610 41611 41612 41613 41614 41615 41616 41617 41618 41619 41620 41632 41633 41634 41635 41636 41637 41638 41639 Q-1034 Catalog/Code Numbers: AVOX4000-110 and AVOX4000-220.
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 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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