medical Class II Updated 2022-04-06

Diagnos Inc recalls CARA (Computer Assisted Retinal Analysis), Product ID: +B543

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: CA
Lot/Code Info: Software Version 4.7.2
View official government recall

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