FDA Medical Device Recalls (openFDA)
Diagnos Inc: CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
- Recall number
- Z-0826-2022
- Recalling firm
- Diagnos Inc
- Product
- CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
- Status
- Terminated
- Initiated
- 2022-01-11
- Posted
- not on file
- Terminated
- 2024-06-18
- 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.
- 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 mmassue@diagnos.ca
- Quantity
- 1
- Distribution
- US: CA
- Lot, serial or model codes
- Software Version 4.7.2
- 510(k) numbers
- ["K110869"]
- PMA numbers
- not on file
- Product code
- NFJ
- Firm FEI
- 3009422347
- Firm city
- Brossard
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28