Siemens Medical Solutions USA, Inc: Device Recall

Recall #Z-2529-2025 · 08/12/2025

Class II: Risk

Recall Details

Recall Number: Z-2529-2025
Classification: Class II
Product Type: Device
Recalling Firm: Siemens Medical Solutions USA, Inc
Status: Ongoing
Date Initiated: 08/12/2025
Location: Malvern, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 20 units

Reason for Recall

Limited system movements after startup .

Product Description

Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

Distribution Pattern

US Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT.

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.