# FDA recall Z-0826-2022

> **Diagnos Inc** · Class II · device recall initiated 2022-01-11.

## 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.

## Distribution

US: CA

## Key facts

- **Recall number:** Z-0826-2022
- **Recalling firm:** Diagnos Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-11
- **Report date:** 2022-04-06
- **Termination date:** 2024-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brossard, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0826-2022

## Citation

> AI Analytics. FDA recall Z-0826-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0826-2022. Source: US FDA. Licensed CC0.

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