ARTIS One Angiographic X-Ray System
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
23 Distributed in the US
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0922-2025