Golden, CO, United States
Cuattro LLC recalls
1 recall recorded since 2018, most recently on 15 October 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
- 15 October 2019
- Terminated
- 27 April 2021
- Reason
- There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
- Distribution
- US: NJ, MI, SC, NC, MI, AR, OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1934-2020
- CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
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.