Events

Recall of Device Recall AVOXimeter 1000

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-1237-2008
  • 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=68273
  • 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 DQA
  • 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 1000
  • Model / Serial
    Serial Numbers: 1073, 1085, 1197, 1245, 1321, 1383, 1162. Catalog Numbers/Code: AVON1000-110 and AVOX-1000-220.  Note:w The AVOXimeter 1000 was discontinued in 1996 by the company which which ITC acquired the product line from (AVOX Systems in Texas. Today, only service is offered on this mode.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • 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 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220
  • Manufacturer
    International Technidyne Corp.

Manufacturer

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