FDA Recall
Terminated
Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Recall: Z-0820-2020
·
Initiated December 31, 2019
Recall
- Recall Number
- Z-0820-2020
- Event Number
- 84615
- Firm
- Koios Medical, Inc.
- FEI Number
- 3010119782
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 31, 2019
- Terminated
- May 7, 2020
- Address
- 500 7th Ave, Fl 8th, New York, NY, 10018-4502
Description
Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
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.
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.
Distribution
Distributed to customers in NY, NJ, and MO.
Quantity
10