medical Class II Updated 2025-02-05

SIEMENS MEDICAL SOLUTIONS USA, INC recalls ARTIS One Angiographic X-Ray System

Recalled Product

ARTIS One Angiographic X-Ray System


Hazard / Issue

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.

Issued by

FDA

Distribution: 23 Distributed in the US
Lot/Code Info: Model Number 10848600
View official government recall

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