Koios DS Breast Software (Koios Medical) – documentation deficiency (2019)
Software documentation gaps may impact product quality procedures.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Brand
Koios Medical, Inc.
Lot Codes / Batch Numbers
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*
Products Sold
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).
Koios Medical, Inc. is recalling Koios DS Breast . The device is a software application which assists skilled physicians in analyzing due to Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to cert. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.
Recommended Action
Per FDA guidance
On 12/31/19, the firm issued Urgent Medical Device Recall letters to affected customers. Customers were advised of the product recall. The firm stated that they would voluntarily and free of charge upgrade all affected customer installed versions with the most recently FDA-cleared product. The firm followed up with email notifications sent on 1/3/2020.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MO, NJ, NY
Page updated: Jan 10, 2026