FDA-Device2020-01-29Class II
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Koios Medical, Inc.
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.
Sold states
Distributed to customers in NY, NJ, and MO.
Affected count
10
Manufactured in
500 7th Ave, 8th Fl, New York, NY, United States
Products
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0820-2020Don't want to check this manually?
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