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Lower risk Medical device recall · FDA · Published January 11, 2022

Diagnos CARA Retinal Analysis Software Recalled: Use Older Version Due to Unapproved AI

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0826-2022Medical deviceDiagnos ›
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Contact the company

Recalling firmDiagnos Inc7005 Taschereau Blvd Suite 265 · Brossard, Canada
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/61276-diagnos-cara-retinal-analysis-software-recalled-use-older-version-due.

Source Summary by GovInfoNow · govinfonow.com/recall/61276-diagnos-cara-retinal-analysis-software-recalled-use-older-version-due · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0826-2022

Cite this page

“Diagnos CARA Retinal Analysis Software Recalled: Use Older Version Due to Unapproved AI.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61276-diagnos-cara-retinal-analysis-software-recalled-use-older-version-due. Based on FDA recall #Z-0826-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0826-2022%22&limit=1).

The FDA announced on Jan. 11, 2022, that Diagnos Inc is voluntarily recalling its CARA (Computer Assisted Retinal Analysis) software due to potentially unapproved artificial intelligence features.

How to tell if you have it

  • Diagnos CARA
  • Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
  • Software Version 4.7.2

The hazard

The retinal analysis system software contains features based on artificial intelligence that potentially lack appropriate market approval.

Context

GovInfoNow's records show other recent recalls of similar products include Siemens CT Software Apps: Unapproved Medical Software Recalled (2025-12-19), Siemens CT Software Applications Recalled: Unapproved Medical Software (2025-12-19), and Siemens CT Software Apps Recalled: Unapproved Medical Use Without FDA Clearance (2025-12-19).

How to tell if you have this one

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.

  • Brand
    Diagnos
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Revert to Older Software Version

    Download and install a prior software version that has received appropriate market approval.

Where it went and when

Where it was distributed

Distributed in California.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “US: CA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Jan 11, 202212. FDA classified it Class II: Mar 25, 202223. Published in FDA’s Enforcement Report: Apr 6, 202234. FDA terminated the recall: Jun 18, 2024420222024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-0826-2022 (January 11, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0826-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA