Date Initiated by Firm |
December 31, 2019 |
Create Date |
January 17, 2020 |
Recall Status1 |
Terminated 3 on May 07, 2020 |
Recall Number |
Z-0820-2020 |
Recall Event ID |
84615 |
510(K)Number |
K161959
|
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product |
Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images. |
Code Information |
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). |
Recalling Firm/ Manufacturer |
Koios Medical, Inc. 500 7th Ave 8th Fl New York NY 10018-4502
|
For Additional Information Contact |
R. Chad McClennan 312-543-1865
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = ClearView Diagnostics Inc.
|