Home / Recalls / Koios Medical, Inc. / Z-0820-2020

Z-0820-2020 Class II Terminated

Recalled by Koios Medical, Inc. — New York, NY

Recall Details

Product Type: Devices
Report Date: January 29, 2020
Initiation Date: December 31, 2019
Termination Date: May 7, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10

Product Description

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

Reason for Recall

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

Distribution Pattern

Distributed to customers in NY, NJ, and MO.

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).