• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AVOXimeter 1000E

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
AVOXimeter 1000E
see related information
Date Posted August 06, 2008
Recall Status1 Terminated on July 24, 2009
Recall Number Z-1238-2008
Recall Event ID 46773
Premarket Notification
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, 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 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 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.
-
-