Brossard, N/A, Canada
Diagnos Inc recalls
1 recall recorded since 2018, most recently on 11 January 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 January 2022
- Terminated
- 18 June 2024
- 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.
- Distribution
- US: CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0826-2022
- CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.