Z-0826-2022Class II

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

Name: Z-0826-2022 CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Creator: Diagnos Inc
Published: 2022-01-11
License: https://open.fda.gov/license/

Diagnos Inc / initiated 2022-01-11 / Terminated / root cause: software

FDA source

Diagnos Inc began a recall of CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 on 2022-01-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0826-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-11
Posted: 2022-03-25
Terminated: 2024-06-18
Recalling firm: Diagnos Inc
Product: CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Product code: NFJ System, Image Management, Ophthalmic
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.
Root cause tag: software
FDA root cause: No Marketing Application
Action: On 01/11/22, a recall notice was emailed to the firm's customer who was informed to immediately cease using the affected software. The only version of software cleared for commercialization is CARA v1.2.1. The customer was asked to contact a quality management representative if they had questions or comments at 1-405-678-8882 ext. 235 or [email protected]
Quantity in commerce: 1
Distribution: US: CA
Product codes and lots: Software Version 4.7.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0826-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0826-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-06	2022-03-25

Product code NFJ

K110869Class IICaraDiagnos, Inc. / cleared 2011-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)