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Koios Medical Recalls

1 recall on record · January 29, 2020 to January 29, 2020 · Medical Devices

January 29, 2020Medical DevicesFDA

Koios Medical, Inc. recalls Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast

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.

Koios Medical Recalls | RecallWatchUSA