FDA Device recall Z-0820-2020
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images
- FDA Device
- Class II
- terminated
- Published 2020-01-29
On 2020-01-29 the FDA classified a Class II recall of Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images by Koios Medical, citing affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0820-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-31 |
| Published | 2020-01-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Koios Medical |
| Distribution | MO, NJ, NY |
Product
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.
Identifiers
| code_info | Models/Versions: 1.2.df61abccd836; 1.2.576fd5569198; 1.3.51a5fadf18dd; 1.3.1.b5c53f1fc08d; 1.3.1.694531bfb9c7; 1.3.1.aa…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). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0820-2020%22
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