Recall Z-0820-2020— Koios Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Koios Medical, Inc., initiated 2019-12-31, terminated 2020-05-07. It names one FDA 510(k) clearance: K161959. Product: Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.. Reason: Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures..
- Recalling firm
- Koios Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-31
- Terminated
- 2020-05-07
- Firm location
- New York, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.