New York, NY, United States
Koios Medical, Inc. recalls
1 recall recorded since 2018, most recently on 31 December 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 31 December 2019
- Terminated
- 7 May 2020
- 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.
- Distribution
- Distributed to customers in NY, NJ, and MO.
- Initiated
- Voluntary: Firm initiated
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.