Diagnos Inc Recall 89715
Description: CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Diagnos Inc Recall 89715 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0826-2022 |
| Event ID | 89715 |
| Event Description | CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 |
| Product Type | Devices |
| Distribution | US: CA |
| Quantity | 1 |
| Recall Reason | Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version. |
| Device Classification | 20220406 |
| Device Code Info | Software Version 4.7.2 |
| Center Classification Date | 20220325 |
| Recall Initiation Date | 20220111 |
| Recalling Firm | Diagnos Inc |
| Initial Notification | Letter |
| Similar To |