Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

ARTIS One Angiographic X-Ray System

FDA Recall Z-0922-2025 · Posted 2025-01-29

Recalling FirmSIEMENS MEDICAL SOLUTIONS USA, INC
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2025-01-02
Product Quantity1140

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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

23 Distributed in the US

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑