Recall Z-1537-2015— GA Industries
Class II · Terminated
Class II FDA medical device recall by GA Industries, initiated 2015-04-06, terminated 2015-11-23. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- GA Industries
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-06
- Terminated
- 2015-11-23
- Firm location
- Palos Verdes Estates, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.