Reported Jan 29, 2020 · Terminated
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast…
Koios Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Koios Medical, Inc. · 500 7th Ave · New York, NY · 10018-4502
Is this the product you have?
- Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
- Lot codes and dates
- Models/Versions1.2.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*; 1.6.2.1* *Note: versioning scheme was modified to encompass the Build/Commit Number into a fourth digit with the development of version 1.5 (which was never distributed)
- Amount recalled
- 10
Where it was sold
Why it was recalled
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.
This product could cause temporary or reversible health problems — stop using it.
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