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Koios Medical, Inc. recalls Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast
Recalled January 29, 2020 · FDA recall Z-0820-2020 · Koios Medical
Hazard
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures. · FDA Class II
Units
10
Sold at
Distributed to customers in NY, NJ, and MO.
Description
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.
Manufacturer(s)
Koios Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →