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 |
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