• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device 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
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
Recalling Firm/
Manufacturer
International Technidyne Corp.
6-8 Olsen Ave
Edison NJ 08820-2419
732-548-5700
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 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.
-
-