Diagnos Inc recalls CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179

Recall date

January 11, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0826-2022

FDA classification

Class II

Brand / firm

Diagnos Inc

Sold / distributed

US: CA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179