Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AVOXimeter 4000

  • 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 4000 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-1239-2008
Recall Event ID 46773
510(K)Number K951485  
Product Classification oximeter - 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 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 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 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 = JKS and Original Applicant = A-VOX SYSTEMS, INC.
-
-