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Class 2 Device Recall AVOXimeter 1000 |
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Date Initiated by Firm |
February 13, 2008 |
Date Posted |
August 06, 2008 |
Recall Status1 |
Terminated 3 on July 24, 2009 |
Recall Number |
Z-1237-2008 |
Recall Event ID |
46773 |
510(K)Number |
K922075
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Product Classification |
oximeter - Product Code DQA
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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 NJ 08820-2419
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For Additional Information Contact |
John Salerno 732-548-5700
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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.
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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 |
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
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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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = DQA and Original Applicant = A-VOX SYSTEMS, INC.
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