BEUDAMED
    FDA Recall Terminated

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool

    Recall: Z-1537-2015 · Initiated April 6, 2015

    Recall

    Recall Number
    Z-1537-2015
    Event Number
    70836
    Firm
    GA Industries
    FEI Number
    3005247627
    Product Code
    MYN
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    April 6, 2015
    Posted
    April 27, 2015
    Terminated
    November 23, 2015
    Address
    4150 Maritime Rd, Palos Verdes Estates, CA, 90275-6061

    Description

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool

    Reason

    GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product release.

    Action

    A Medical Device Correction and Removal Notice dated 3/25/15 will be sent to customers on 4/7/15 to inform them that GA Industries is providing them with a new approved version of Logicon Caries Detector, Version 5.1. The letter informs customers that the original version 5.0 should be uninstalled from their computers and the installation CD be destroyed. The letter informs the customers of the changes and improvements to the product. Customers are instructed to join training sessions conducted by Carestream that demonstrates the new features. Customers are instructed to contact [email protected] for webinar schedule. Customers with questions are instructed to contact GA Industries at logiconsupport@carestream or at (800) 944-6365.

    Distribution

    US Nationwide Distribution

    Quantity

    825 units