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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- GA Industries
- Category
- Medical Device — Dental Software
- Affected units
- 825
Distribution
Distributed nationwide across the United States.
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