Recall Z-0826-2022— Diagnos Inc

Name: FDA recall Z-0826-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-11

Class II · Terminated

Class II FDA medical device recall by Diagnos Inc, initiated 2022-01-11, terminated 2024-06-18. It names one FDA 510(k) clearance: K110869. Product: CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179. 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: Diagnos Inc
Classification: Class II
Status: Terminated
Initiated: 2022-01-11
Terminated: 2024-06-18
Firm location: Brossard, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K110869 — CARADiagnos, Inc.·cleared 2011-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.