06
Apr
2022

Recall – Retinal analysis system software lacks market approval

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0

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

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