—#211984

Product

ARTIS One Angiographic X-Ray System

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133580
Affected lot / code info: Model Number 10848600

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Recalling firm

Firm: SIEMENS MEDICAL SOLUTIONS USA, INC
Address: 40 Liberty Blvd, Malvern Germany,

Distribution

Distribution pattern: 23 Distributed in the US

Timeline

Recall initiated: 2025-01-02
Posted by FDA: 2025-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211984. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.