The Recall Desk
SevereFDA (Devices)·Z-2660-2025·Announced 2025-10-08

MRI System Helium Venting Malfunction Poses Pressure Leak Risk

Siemens MAGNETOM Skyra MRI systems may have ice blockages in the helium venting system, potentially preventing gas escape during a quench event. This could cause pressure buildup and rupture the helium containment system, releasing helium into the scanning room.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification mandates a minimum severity of 4. The hazard involves potential equipment rupture and pressurized gas leak under specific operational conditions (quench event), creating a risk of harm despite no reported injuries to date.

Plain-English summary

Siemens Medical Solutions is recalling 586 MAGNETOM Skyra MRI systems (Model Number 10432915) distributed worldwide. The systems have a potential for ice blockage to form in the magnet venting system.

During a quench event, helium gas is designed to escape safely through designated venting paths. If ice blockage forms or already exists, helium may be unable to escape through these paths. This can lead to pressure buildup within the helium containment system. The pressure buildup could potentially rupture the helium containment system and result in a helium leak into the scanning room.

These devices have been distributed to healthcare facilities worldwide.

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 — Diagnostic Imaging / MRI
Hazard
  • pressure-buildup
  • helium-leak
  • equipment-rupture

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.

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