Z-0820-2020 Class II Terminated
FDA device recall Z-0820-2020 was initiated by Koios Medical, Inc. on December 31, 2019 and is designated Class II. 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. The recall status is terminated (terminated May 7, 2020). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2020
- Initiation Date
- December 31, 2019
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
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.
Distribution Pattern
Distributed to customers in NY, NJ, and MO.
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).