BEUDAMED
    FDA Recall Terminated

    International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220

    Recall: Z-1239-2008 · Initiated February 13, 2008

    Recall

    Recall Number
    Z-1239-2008
    Event Number
    46773
    Firm
    International Technidyne Corp.
    FEI Number
    1000526865
    Product Code
    JKS
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    February 13, 2008
    Posted
    August 6, 2008
    Terminated
    July 24, 2009
    Address
    6-8 Olsen Ave, Edison, NJ, 08820-2419

    Description

    International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220

    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.

    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.

    Quantity

    61 US, 2 International