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U.S. Department of Health and Human Services

Class 2 Device Recall AVOXimeter 1000E

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  Class 2 Device Recall AVOXimeter 1000E see related information
Date Initiated by Firm February 13, 2008
Date Posted August 06, 2008
Recall Status1 Terminated 3 on July 24, 2009
Recall Number Z-1238-2008
Recall Event ID 46773
510(K)Number K922075  
Product Classification oximeter - Product Code DQA
Product International Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers: AVOX1000E-110 and AVOX1000E-220
Code Information 1482  1531  1627  1633  1635  1707  1708  1716  1740  1804  1864  1961  1968  1991  1997  2002  2082  2094  2109  2148  2157  2164  2212  2238  2271  2282  2315  2319  2331  2384  2388  2394  2395  2449  2585  2596  2598  2633  2657  2669  2686  2689  2725  2728  2732  2741  2742  2743  2744  2746  2747  2748  2749  2750  2751  2752  2753  2754  2755  2756  2757  2758  2759  2760  2761  2762  2763  2764  2765  2766  2767  2769  2771  2772  2773  2774  2775  2776  2777  2778  2779  2780  2794  2806  2807  2808  2810  2812  2813  2814  2815  2816  2817  2818  2819  2820  2821  2822  2823  2824  2825  2826  2827  2828  2831  2832  2833  2834  2835  2836  2837  2839  2843  2844  2845  2846  2848  2849  2850  2851  2852  2853  2854  2855  2856  2857  2858  2859  2860  2861  2863  2864  2865  2866  2867  2868  2869  2870  2871  2872  2873  2874  2875  2876  2877  2878  2879  2880  2881  2882  2883  2884  2885  2887  2888  2889  2890  2891  2892  2894  2895  2896  2898  2899  2900  2901  2902  2903  2904  2905  2906  2907  2908  2909  2910  2912  2913  2914  2915  2917  2918  2921  2922  2924  2925  2926  2927  2928  2929  2932  2933  2934  2935  2936  2937  2938  2939  2940  2942  2943  2944  2945  2946  2947  2948  2950  Catalog/Code Numbers: AVOX1000E-110 and AVOX1000E-220.  
Recalling Firm/
Manufacturer		 International Technidyne Corp.
6-8 Olsen Ave
Edison NJ 08820-2419
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 164 US; 39 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 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.
510(K) Database 510(K)s with Product Code = DQA and Original Applicant = A-VOX SYSTEMS, INC.
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