SIEMENS MEDICAL SOLUTIONS USA, INC: Device Recall

Recall #Z-0922-2025 · 01/02/2025

Class II: Risk

Recall Details

Recall Number: Z-0922-2025
Classification: Class II
Product Type: Device
Recalling Firm: SIEMENS MEDICAL SOLUTIONS USA, INC
Status: Ongoing
Date Initiated: 01/02/2025
Location: Malvern, Germany
Product Quantity: 1140

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.

Product Description

ARTIS One Angiographic X-Ray System

Distribution Pattern

23 Distributed in the US

Other Recalls by SIEMENS MEDICAL SOLUTIONS USA, INC

Class II: Risk 12/29/2025

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II: Risk 12/29/2025

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II: Risk 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

View all recalls by SIEMENS MEDICAL SOLUTIONS USA, INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.