BEUDAMED
    FDA Recall Terminated

    ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a tool for the pre-surgical planning of the placement of dental implants and pre-surgical fabrication of stents to aid in dental implant insertion. In addition, it is used for diagnostics and treatment planning in orthodontic, ENT and similar applications.

    Recall: Z-2239-2009 · Initiated August 3, 2009

    Recall

    Recall Number
    Z-2239-2009
    Event Number
    53132
    Firm
    IMTEC IMAGING L.L.C.
    FEI Number
    1000118617
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 3, 2009
    Posted
    September 22, 2009
    Terminated
    January 27, 2010
    Address
    2401 N Commerce St, Ardmore, OK, 73401-1280

    Description

    ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a tool for the pre-surgical planning of the placement of dental implants and pre-surgical fabrication of stents to aid in dental implant insertion. In addition, it is used for diagnostics and treatment planning in orthodontic, ENT and similar applications.

    Reason

    Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.

    Action

    Firm sent notifications to all ILUMAVision customers on 8/3/2009 and offered upgraded software. The notification letter indicated the the reason for the recall and identified the potential issues associated with the device. Contact 3M IMTEC Technical Support at 1.800.879.9799, if there are any questions.

    Distribution

    Worldwide - US - Foreign: Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Egypt, France, Germany, Hong Kong, Italy, Korea, Malaysia, Mexico, The Netherlands, Poland, Saudi Arabia, Spain, Turkey, and United Kingdom

    Quantity

    223