Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Koios DS Breast <series 1.0>. The device is a software Recalled by Koios Medical, Inc. Due to Affected software product versions were found during internal...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Koios Medical, Inc. directly.
Affected Products
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Quantity: 10
Why Was This Recalled?
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.
Where Was This Sold?
This product was distributed to 3 states: MO, NJ, NY
About Koios Medical, Inc.
Koios Medical, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report