The Recall Desk
Severity pendingFDA (Devices)·Z-2654-2025·Announced 2025-10-08

Biograph mMR. Model Number: 10433372.

Pending LLM rewrite. Source: FDA_DEVICE Z-2654-2025.

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
Biograph mMR. Model Number: 10433372.
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: 10433372. UDI Number: (01)04056869006741(21)151032
  • (01)04056869006741(21)151057
  • (01)04056869006741(21)510535
  • (01)04056869006741(21)151034
  • (01)04056869006741(21)51003
  • (01)04056869006741(21)151021
  • (01)04056869006741(21)51055
  • (01)04056869006741(21)151013
  • (01)04056869006741(21)51064
  • (01)04056869006741(21)151044
  • (01)04056869006741(21)51038
  • (01)04056869245188(21)51006
  • (01)04056869006741(21)51030
  • (01)04056869006741(21)151004
  • (01)04056869006741(21)51022
  • (01)04056869006741(21)151049
  • (01)04056869006741(21)51007
  • (01)04056869006741(21)151045
  • (01)04056869006741(21)51032
  • (01)04056869006741(21)51057

Distribution

Distributed nationwide across the United States.

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