GA Industries Recalls Logicon Caries Detector for Lack of FDA Approval
GA Industries is recalling the Logicon Caries Detector software because it was released without FDA approval.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation and regulatory compliance issue (lack of FDA approval) rather than a physical defect or reported health hazard, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental. The product is a software tool used to analyze inter-proximal tooth surfaces for decay using digital radiographs.
The recall was initiated because the product was not submitted for approval to the FDA prior to its release. This regulatory non-compliance means the device was distributed without the required pre-market authorization.
The recall affects 825 units distributed nationwide in the United States. Affected serial numbers range from 120001 to 120825. Users should stop using the software and contact GA Industries for further instructions.
The recalled product
- 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 dire
- Manufacturer
- GA Industries
- Category
- Medical Device — Dental Software
- Affected units
- 825
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01