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FDAJanuary 2, 2025device

ARTIS One Angiographic X-Ray System

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

siemens medical solutionssiemenssiemens medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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ARTIS One Angiographic X-Ray System — Recall Details · AllClear