Class II — Koios Medical, Inc.
| Recalling firm | Koios Medical, Inc. |
|---|---|
| Registered facility | Koios Medical, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images. |
| Quantity | 10 |
| Distribution | Distributed to customers in NY, NJ, and MO. |
| Initiated | 2019-12-31 |
| Classified | 2020-01-17 |
| Terminated | 2020-05-07 |
| Recall number | Z-0820-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Koios Medical, Inc. (Z-0820-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84615/
Alerts for Koios Medical, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.