Koios Medical, Inc. Recall: Koios DS Breast <series 1.0>. The device is a software applica
Koios Medical, Inc. Recall: Koios DS Breast <series 1.0>. The device is a software applica is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Koios Medical, Inc.; Product: Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing brea
| Recalling firm | Koios Medical, Inc. |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Distributed to customers in NY, NJ, and MO. |
| Recall initiated | 20191231 |
| Recall number | Z-0820-2020 |
| Category | device |
| State | NY |
| Country | United States |
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