Class II
Medical Device Recall: ARTIS One Angiographic X-Ray System
SIEMENS MEDICAL SOLUTIONS USA, INC · January 2, 2025
Reason for Recall
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.
Distribution
23 Distributed in the US
States Affected
IN
Quantity Affected
1140
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0922-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.