Agency classClass IOur severity:Critical FDA (Devices)·Z-2660-2025·Announced 2025-10-08

MAGNETOM Skyra MRI systems recalled over ice blockage in venting system

Siemens is recalling 586 MAGNETOM Skyra (DE) 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 Skyra (DE) MRI systems, model number 10432915, 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 586 units, 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 Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — MRI system
Hazard: helium-leak
pressure-buildup
venting-failure
quench
Affected units: 586

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model Number: 10432915. UDI Numbers: (01)04056869006703(21)45046
(01)04056869006703(21)45115
(01)04056869006703(21)45398
(01)04056869006703(21)145760
(01)04056869006703(21)145811
(01)04056869006703(21)45549
(01)04056869006703(21)45834
(01)04056869006703(21)146099
(01)04056869006703(21)146110
(01)04056869006703(21)45047
(01)04056869006703(21)146093
(01)04056869006703(21)46066
(01)04056869006703(21)45788
(01)04056869006703(21)146082
(01)04056869006703(21)45124
(01)04056869006703(21)45185
(01)04056869006703(21)45332
(01)04056869006703(21)45466
(01)04056869006703(21)145390
(01)04056869006703(21)45732

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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