FDA recall Z-0820-2020

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.

Distribution

Distributed to customers in NY, NJ, and MO.

Key facts

Status

Terminated

Initiation date

2019-12-31

Report date

2020-01-29

Termination date

2020-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0820-2020