Logicon Caries Detector Product Usage: Analyze inter-proximal tooth… — Class II medical device recall Z-1537-2015
Terminated recall by GA Industries, reported 2015-05-06, distributed nationwide. GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not
| Recall number | Z-1537-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GA Industries, Palos Verdes Estates, CA, United States |
| Recall initiated | 2015-04-06 |
| Classified | 2015-04-27 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-11-23 |
| Distributed | Nationwide (US) |
| Quantity | 825 units |
| 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 and 475 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1537-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.