Class II — Diagnos Inc
| Recalling firm | Diagnos Inc. |
|---|---|
| Registered facility | DIAGNOS INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 |
| Quantity | 1 |
| Distribution | US: CA |
| Initiated | 2022-01-11 |
| Classified | 2022-03-25 |
| Terminated | 2024-06-18 |
| Recall number | Z-0826-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Diagnos Inc (Z-0826-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89715/
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