Koios Medical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0820-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 31, 2019

Date Posted: January 29, 2020

Recall Number: Z-0820-2020

Event ID: 84615

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.

Status: Terminated

Product Quantity: 10

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.

Voluntary or Mandated:

Voluntary: Firm initiated