CARA — Class II medical device recall Z-0826-2022
Terminated recall by Diagnos Inc, reported 2022-04-06, distributed in CA. Retinal analysis system software has some features, based on artificial intelligence, that potentially lack ap
| Recall number | Z-0826-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnos Inc, Brossard, N/A, Canada |
| Recall initiated | 2022-01-11 |
| Classified | 2022-03-25 |
| Reported by FDA | 2022-04-06 |
| Terminated | 2024-06-18 |
| Distributed | CA |
| Quantity | 1 |
| Reason classes | software |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0826-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.