FDA Device recall Z-0826-2022
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
- FDA Device
- Class II
- terminated
- Published 2022-04-06
On 2022-04-06 the FDA classified a Class II recall of CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 by Diagnos, citing 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 pri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0826-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-11 |
| Published | 2022-04-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Diagnos |
| Distribution | CA |
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.
Identifiers
| code_info | Software Version 4.7.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0826-2022%22
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