Koios Medical recalls software versions 1.2 to 1.6 for breast ultrasound analysis due to insufficient quality documentation. Affected versions may not meet regulatory standards.
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.
Koios Medical recalls specific software versions for breast ultrasound analysis that were sold without proper quality documentation. This could mean the software doesn't meet required safety standards, potentially affecting medical accuracy.
The software versions were marketed without sufficient documentation for required quality procedures. This could lead to the software not meeting regulatory standards, but does not cause immediate physical harm.
Skilled physicians using Koios DS Breast software versions 1.2 to 1.6 for breast ultrasound analysis. The risk is low as the issue relates to documentation, not direct harm.
Check if your software version is listed: 1.2.df61abccd836, 1.2.576fd5569198, 1.3.51a5fadf18dd, 1.3.1.b5c53f1fc08d, 1.3.1.694531bfb9c7, 1.3.1.aaffb0cc2485, 1.3.2.6a67eb8088ed, 1.4.a7e352273dd6, 1.6.1.1*, or 1.6.2.1*.
Identify your software version by checking the version number in the application settings.
The software versions were marketed without sufficient documentation for required quality procedures.
No, the recall does not require stopping use; it relates to documentation, not immediate safety risks.
Check your software version to see if it is affected; no action is needed if it is not listed.
We’ve drafted a message you can send Koios to request your refund or repair — edit it as you like.
Subject: Recall Z-0820-2020 — Koios Koios Hello, I own a Koios that is covered by recall Z-0820-2020 from Koios. 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.
