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

Recall date

April 6, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1537-2015

FDA classification

Class II

Brand / firm

GA Industries

Sold / distributed

US Nationwide Distribution

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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