FDAJanuary 11, 2022device
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
diagnos
Recall history
No related federal recalls on record for this brand yet.
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →