Recall Z-0826-2022 ยท NFJ System, Image Management, Ophthalmic
Diagnos Inc
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
| Date | Jan 11, 2022 |
| Status | Terminated |
| 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. |
| Root cause | No Marketing Application |
| Action | On 01/11/22, a recall notice was emailed to the firm's customer who was informed to immediately cease using the affected software. The only version of software cleared for commercialization is CARA v1.2.1. The customer was asked to contact a quality management representative if they had questions or comments at 1-405-678-8882 ext. 235 or mmassue@diagnos.ca |
| Quantity | 1 |
| Distribution | US: CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110869 | CARA Diagnos, Inc., Jul 14, 2011 |