Siemens Medical Solutions USA, Inc recalls MAGNETOM Cima.X Upgrade. Model Number: 11689304.

Recall date

October 1, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0431-2026

FDA classification

Class I

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

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

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

MAGNETOM Cima.X Upgrade. Model Number: 11689304.