Retinal Analysis Software with Potentially Unapproved AI Features Recalled
Diagnos Inc is recalling CARA retinal analysis software version 4.7.2 because some AI-based features may lack appropriate FDA market approval. Users are advised to revert to a prior software version.
- Product
- CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
- Category
- Medical Device
- Distribution
- 1 state