FDA-Device2025-02-05Class II
ARTIS One Angiographic X-Ray System
Hazard
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.
Sold states
23 Distributed in the US
Affected count
1140
Manufactured in
40 Liberty Blvd, Malvern, Germany
Products
ARTIS One Angiographic X-Ray System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0922-2025More SIEMENS MEDICAL SOLUTIONS USA, INC recalls
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