Diagnos Inc recalls CARA retinal analysis software version 4.7.2 due to unapproved AI features. Users should revert to a prior software version to avoid potential risks.
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.
Diagnos Inc has recalled its CARA retinal analysis software version 4.7.2 because it includes AI features that lack proper market approval. Using this version could pose risks compared to older, approved software versions.
The software includes AI features that have not been properly approved by regulatory authorities. This means the software might not meet safety standards for medical use, potentially leading to inaccurate results or other issues.
Users of the CARA retinal analysis software version 4.7.2 are affected. Eye care professionals who use this software for retinal analysis are most at risk.
Check if your CARA software version is 4.7.2. The product ID is +B543CARA0/$$+7V4.7.2/16D202111179. This version was sold starting in 2021.
Download and install a prior software version that has received appropriate market approval.
The software includes AI features that lack appropriate market approval, so it is recommended to use a specific prior software version.
Revert to an older software version that has received appropriate market approval.
The recall is due to unapproved AI features, not a direct risk of injury. The hazard is potential inaccuracies in retinal analysis results.
We’ve drafted a message you can send Diagnos to request your refund or repair — edit it as you like.
Subject: Recall Z-0826-2022 — Diagnos Diagnos Hello, I own a Diagnos that is covered by recall Z-0826-2022 from Diagnos. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
