Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

MAGNETOM Cima.X Upgrade. Model Number: 11689304. Recalled by Siemens Medical Solutions USA, Inc Due to There is a potential for an ice blockage...

Date: October 1, 2025
Company: Siemens Medical Solutions USA, Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Medical Solutions USA, Inc directly.

Affected Products

MAGNETOM Cima.X Upgrade. Model Number: 11689304.

Quantity: 4 system (1 US; 3 OUS)

Why Was This 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.

Where Was This Sold?

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

About Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc has 613 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report