FDA Device recall Z-1537-2015
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic ass…
- FDA Device
- Class II
- terminated
- Published 2015-05-06
On 2015-05-06 the FDA classified a Class II recall of Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic ass… by Ga Industries, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1537-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-06 |
| Published | 2015-05-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ga Industries |
| Distribution | US |
Product
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.
Identifiers
| code_info | Serial Numbers: 120001 120002 120003 120004 120005 120006 120007 120008 120009 120010 120011 120012 120013…Serial Numbers: 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 120062 120063 120064 120065 120066 120067 120068 120069 120070 120071 120072 120073 120074 120075 120076 120077 120078 120079 120080 120081 120082 120083 120084 120085 120086 120087 120088 120089 120090 120091 120092 120093 120094 120095 120096 120097 120098 120099 120100 120101 120102 120103 120104 120105 120106 120107 120108 120109 120110 120111 120112 120113 120114 120115 120116 120117 120118 120119 120120 120121 120122 120123 120124 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1537-2015%22
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