The Recall Desk
Severity pendingFDA (Devices)·Z-2659-2025·Announced 2025-10-08

MAGNETOM Prisma. Model Number: 10849582.

Pending LLM rewrite. Source: FDA_DEVICE Z-2659-2025.

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 Prisma. Model Number: 10849582.
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: 10849582. UDI Numbers: (01)04056869006727(21)166324
  • (01)04056869006727(21)66104
  • (01)04056869006727(21)166097
  • (01)04056869006727(21)166024
  • (01)04056869006727(21)166018
  • (01)04056869006727(21)66109
  • (01)04056869006727(21)66111
  • (01)04056869006727(21)166114
  • (01)04056869006727(21)166242
  • (01)04056869006727(21)166268
  • (01)04056869006727(21)166200
  • (01)04056869006727(21)166047
  • (01)04056869006727(21)66047
  • (01)04056869006727(21)166292
  • (01)04056869006727(21)166041
  • (01)04056869006727(21)166007
  • (01)04056869006727(21)166037
  • (01)04056869006727(21)66112
  • (01)04056869006727(21)166025
  • (01)04056869006727(21)166003

Distribution

Distributed nationwide across the United States.

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