Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0826-2022

January 11, 2022

Class II

Product summary

Firm
Diagnos Inc
Event
Event 89715
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0826-2022

Official wording

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.

Code information: Software Version 4.7.2

Distribution pattern: US: CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.