Company: Diagnos Inc.
Date of Enforcement Report: 4/6/2022
Class II
PRODUCT
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Recall Number:
Z-0826-2022
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.
RECALLING FIRM/MANUFACTURER
Diagnos Inc. on 1/11/2022. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
1
DISTRIBUTION
U.S. Nationwide