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# Siemens Healthineers Warning on MRI Machines
- URL: https://www.fdaweb.com/siemens-healthineers-warning-on-mri-machines/
- Published: 2025-11-19T12:00:00.000Z
- Updated: 2026-09-14T15:27:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160250

Siemens Healthineers has issued an urgent safety correction (Class 1 recall) for dozens of its 3 Tesla MRI models after identifying a potentially catastrophic failure involving the systems’ magnet venting pathways. The alert covers many of the company’s high-field MRI systems, including MAGNETOM Verio, Skyra, Prisma, Vida, Lumina, Cima.X, and several PET-MRI hybrid Biograph mMR units sold in the U.S. and internationally.

The issue involves the possibility of ice forming inside the magnet’s venting system. If the MRI magnet suddenly loses superconductivity — a rare but dangerous event known as a “quench” — super-cold helium gas is supposed to rapidly escape through designated vents, a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/alert-siemens-healthineers-issues-correction-3-tesla-mri-systems?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. Siemens warned that an ice blockage could trap helium inside the containment system instead, causing dangerous internal pressure buildup. In a worst-case scenario, the containment system could rupture, sending a massive volume of helium into the MRI room and potentially creating an explosion-like force.

To date, Siemens said it is not aware of any injuries or deaths tied to the defect.