FDAApril 6, 2015device
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 poten...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
ga
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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