Events

Recall of Device Recall AVOXimeter 4000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by International Technidyne Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    46773
  • Event Risk Class
    Class 2
  • Event Number
    Z-1239-2008
  • Event Initiated Date
    2008-02-13
  • Event Date Posted
    2008-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68275
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    oximeter - Product Code JKS
  • Reason
    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.
  • 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.

Device

Device Recall AVOXimeter 4000
  • Model / Serial
    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.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220
  • Manufacturer
    International Technidyne Corp.

Manufacturer

International Technidyne Corp.
  • Manufacturer Address
    International Technidyne Corp., 6-8 Olsen Ave, Edison NJ 08820-2419
  • Source
    USFDA