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Diagnos Inc recalls CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Recalled April 6, 2022 · FDA recall Z-0826-2022 · Diagnos
Hazard
Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version. · FDA Class II
Units
1
Sold at
US: CA
Description
Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.
Product
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Manufacturer(s)
Diagnos Inc
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →