Recall Z-0820-2020 ยท LLZ System, Image Processing, Radiological
Koios Medical, Inc.
Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
| Date | Dec 31, 2019 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161959 | ClearView cCAD Clearview Diagnostics, Inc., Dec 28, 2016 |