Z-0820-2020Class II

Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast...

Name: Z-0820-2020 Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast...
Creator: Koios Medical, Inc.
Published: 2019-12-31
License: https://open.fda.gov/license/

Koios Medical, Inc. / initiated 2019-12-31 / Terminated / root cause: software

FDA source

Koios Medical, Inc. began a recall of Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images on 2019-12-31. FDA classified it as Class II and gives the reason as "Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0820-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-31
Posted: 2020-01-17
Terminated: 2020-05-07
Recalling firm: Koios Medical, Inc.
Product: Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA 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 in commerce: 10
Distribution: Distributed to customers in NY, NJ, and MO.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0820-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0820-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-17

Product code LLZ

K161959Class IIClearView cCADClearview Diagnostics, Inc. / cleared 2016-12-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)