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U.S. Department of Health and Human Services

Class 2 Device Recall Koios DS Breast series 1.0 Image Processing System.

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  Class 2 Device Recall Koios DS Breast series 1.0 Image Processing System. see related information
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.
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