Koios DS Breast <series 1 — Class II medical device recall Z-0820-2020
Terminated recall by Koios Medical, Inc., reported 2020-01-29, distributed in MO, NJ, NY. Affected software product versions were found during internal audit to have been marketed for sale without suf
| Recall number | Z-0820-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Koios Medical, Inc., New York, NY, United States |
| Recall initiated | 2019-12-31 |
| Classified | 2020-01-17 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2020-05-07 |
| Distributed | MO, NJ, NY |
| Quantity | 10 |
| Reason classes | software |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0820-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.