Siemens Medical Solutions USA, Inc: Medical Device Recall in 2025 - (Recall #: Z-0431-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

MAGNETOM Cima.X Upgrade. Model Number: 11689304.

Product Classification:

Class I

Date Initiated: October 1, 2025

Date Posted: November 19, 2025

Recall Number: Z-0431-2026

Event ID: 97845

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.

Status: Ongoing

Product Quantity: 4 system (1 US; 3 OUS)

Code Information:

Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated