Koios Medical, Inc. recalls Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast…
- Recall date
- December 31, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0820-2020
- FDA classification
- Class II
- Brand / firm
- Koios Medical, Inc.
- Sold / distributed
- Distributed to customers in NY, NJ, and MO.
Why it was recalled
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
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