Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.

Reason: Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.

Code information: Models/Versions: 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*; 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).

Distribution pattern: Distributed to customers in NY, NJ, and MO.