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

Biograph mMR Medical Device Magnet Venting System Ice Blockage Risk

Siemens recalls the Biograph mMR imaging device due to potential ice blockage in the magnet venting system. This could cause helium pressure build-up and containment rupture, potentially leaking 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: This is an FDA Class I recall of a critical medical device. Although no injuries or deaths have been reported, the potential for helium containment rupture and gas leak into occupied scanning rooms presents a significant hazard meeting FDA Class I standards.

Plain-English summary

The Biograph mMR medical imaging device (Model 10433372) from Siemens Medical Solutions USA, Inc is being recalled due to a potential ice blockage that can form in the magnet venting system.

If a magnet quench event occurs, helium gas may be unable to properly escape through the designed venting paths due to the ice blockage. This obstruction can cause pressure to build up within the helium containment system. The pressure build-up could potentially rupture the helium containment system, resulting in a helium leak into the scanning room.

Approximately 27 units are affected by this recall and have been distributed worldwide. Facility operators and medical professionals using this device should contact Siemens Medical Solutions USA, Inc for instructions on how to address this issue.

The recalled product

Product
Biograph mMR. Model Number: 10433372.
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Medical Imaging
Hazard
  • ice-blockage
  • pressure-buildup
  • rupture
  • gas-leak

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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