Recall Z-1537-2015 ยท MYN Analyzer, Medical Image
GA Industries
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 investigatio
| Date | Apr 27, 2015 (initiated Apr 6, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | A Medical Device Correction and Removal Notice dated 3/25/15 will be sent to customers on 4/7/15 to inform them that GA Industries is providing them with a new approved version of Logicon Caries Detector, Version 5.1. The letter informs customers that the original version 5.0 should be uninstalled from their computers and the installation CD be destroyed. The letter informs the customers of the changes and improvements to the product. Customers are instructed to join training sessions conducted by Carestream that demonstrates the new features. Customers are instructed to contact LogiconSup |
| Quantity | 825 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.