FDA recall Z-0826-2022

Diagnos Inc · Class II · device

Product

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

Reason for recall

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.

Distribution

US: CA

Key facts

Status: Terminated
Initiation date: 2022-01-11
Report date: 2022-04-06
Termination date: 2024-06-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brossard, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0826-2022