FDAFDA · Food and drugs·Recall number Z-0820-2020
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Published January 29, 2020 · Recall initiated: December 31, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Koios Medical, Inc.
- Distributor
- Distributed to customers in NY, NJ, and MO.
- Lot
- 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).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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