Reported May 6, 2015 · Terminated

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs.…

GA Industries

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GA Industries · 4150 Maritime Rd · Palos Verdes Estates, CA · 90275-6061

Is this the product you have?

  • Logicon Caries Detector Product UsageAnalyze 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
Lot codes and dates
  • Serial Numbers

    817 of 817 codes

    • 120001
    • 120002
    • 120003
    • 120004
    • 120005
    • 120006
    • 120007
    • 120008
    • 120009
    • 120010
    • 120011
    • 120012
    • 120013
    • 120014
    • 120015
    • 120016
    • 120017
    • 120018
    • 120019
    • 120020
    • 120021
    • 120022
    • 120023
    • 120024
    • 120025
    • 120026
    • 120027
    • 120028
    • 120029
    • 120030
    • 120031
    • 120032
    • 120033
    • 120034
    • 120035
    • 120036
    • 120037
    • 120038
    • 120039
    • 120040
    • 120041
    • 120042
    • 120043
    • 120044
    • 120045
    • 120046
    • 120047
    • 120048
    • 120049
    • 120050
    • 120051
    • 120052
    • 120053
    • 120054
    • 120055
    • 120056
    • 120057
    • 120058
    • 120060
    • 120061
Amount recalled
825 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 23, 2015 · Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.