FDA Medical Device Recalls (openFDA)
Koios Medical, Inc.: Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
- Recall number
- Z-0820-2020
- Recalling firm
- Koios Medical, Inc.
- Product
- Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
- Status
- Terminated
- Initiated
- 2019-12-31
- Posted
- not on file
- Terminated
- 2020-05-07
- 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.
- Root cause
- Other
- Action
- On 12/31/19, the firm issued Urgent Medical Device Recall letters to affected customers. Customers were advised of the product recall. The firm stated that they would voluntarily and free of charge upgrade all affected customer installed versions with the most recently FDA-cleared product. The firm followed up with email notifications sent on 1/3/2020.
- Quantity
- 10
- Distribution
- Distributed to customers in NY, NJ, and MO.
- Lot, serial or model codes
- Models/Versions: 1.2.df61abccd836; 1.2.576fd5569198; 1.3.51a5fadf18dd; 1.3.1.b5c53f1fc08d; 1.3.1.694531bfb9c7; 1.3.1.aaffb0cc2485; 1.3.2.6a67eb8088ed; 1.4.a7e352273dd6; 1.6.1.1*; 1.6.2.1* *Note: versioning scheme was modified to encompass the Build/Commit Number into a fourth digit with the development of version 1.5 (which was never distributed).
- 510(k) numbers
- ["K161959"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3010119782
- Firm city
- New York
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28