Siemens Medical Solutions USA, Inc: Device Recall

Recall Details

Recall Number

Z-0431-2026

Classification

Class I

Product Type

Device

Recalling Firm

Siemens Medical Solutions USA, Inc

Status

Ongoing

Date Initiated

10/01/2025

Location

Malvern, PA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

4 system (1 US; 3 OUS)

Reason for Recall

There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Product Description

MAGNETOM Cima.X Upgrade. Model Number: 11689304.

Distribution Pattern

US distribution to California. International distribution to Australia, Germany, Great Britian.

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 →