Agency classClass IOur severity:Critical FDA (Devices)·Z-2663-2025·Announced 2025-10-08

MAGNETOM Spectra MRI systems recalled over helium venting ice blockage

Siemens is recalling three MAGNETOM Spectra MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.

Plain-English summary

MAGNETOM Spectra MRI systems, model number 10837643, and MAGNETOM Spectra (CN), model number 10655588, are being recalled because an ice blockage may form, or may already exist, within the magnet venting system.

In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. That pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

The recall covers three units, including serial number 72030, distributed worldwide including nationwide in the United States. The FDA has classified the recall as Class I.

Operating sites should follow the manufacturer's instructions for inspection and correction of the venting system before further use.

The recalled product

Product: MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — MRI system
Hazard: helium-leak
pressure-buildup
venting-failure
quench
Affected units: 3

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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