The Recall Desk
Severity pendingFDA (Devices)·Z-2661-2025·Announced 2025-10-08

MAGNETOM Skyra fit. Model Number: 10849580.

Pending LLM rewrite. Source: FDA_DEVICE Z-2661-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

There is a potential for an ice blockage to form or currently 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. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

The recalled product

Product
MAGNETOM Skyra fit. Model Number: 10849580.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Devices

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: 10849580. UDI Numbers: (01)04056869006710(21)170068
  • (01)04056869006710(21)170053
  • (01)04056869006710(21)70022
  • (01)04056869006710(21)170049
  • (01)04056869006710(21)170018
  • (01)04056869006680(21)162078
  • (01)04056869006710(21)170109
  • (01)04056869006710(21)170039
  • (01)04056869006710(21)170066
  • (01)04056869006710(21)170023
  • (01)04056869006710(21)170030
  • (01)04056869006710(21)170004
  • (01)04056869006710(21)170016
  • (01)04056869006710(21)170077
  • (01)04056869006710(21)170058
  • (01)04056869006710(21)170002
  • (01)04056869006710(21)170050
  • (01)04056869006710(21)170010
  • (01)04056869006710(21)170019
  • (01)04056869006710(21)70026

Distribution

Distributed nationwide across the United States.

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